Pulmonary Disease, Chronic ObstructiveECOPDHIF-1NCT04955977
Physical Exercise and Responses Measured by HIF-1 in COPD
A study testing Physical exercise program and Health education in COPD in people with Pulmonary Disease, Chronic Obstructive, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
Despite being considered a potentially preventable disease, COPD is classified as one of the respiratory problems with the highest prevalence and socioeconomic impact. According to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), people with COPD require actions that optimize quality of life by… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Physical exercise program and Health education in COPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years.
- People with a diagnosis of COPD categorized in GOLD 1,2,3 and 4, with no record of respiratory crises in the last 3 months.
- People with a diagnosis of COPD categorized by lung function in GOLD 1,2,3 and 4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen.
- People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l.
- People who have read and signed informed consent and who have membership in a mandatory health plan.
Who cannot join
- People with a medical diagnosis of anemia, liver disease, chronic kidney disease, rheumatological diseases or a history of gastrointestinal bleeding in the last 2 months.
- People with a diagnosis of COPD who have a history of kidney or liver transplantation.
- People with a diagnosis of COPD who present severity of symptoms and/or respiratory exacerbations categorized in D presenting an mMRC > 2 and CAT > 10 with >1 hospitalization requirements.
- People who are under pharmacological management with erythropoietin (EPO), antibiotics and / or steroids on a chronic basis.
- People with musculoskeletal injuries that limit the execution of the physical training program or that present medical restrictions for the execution of physical exercise.
- People with a diagnosis of COPD who record active smoking.
- People who are participating in research related to medical, pharmacological or physiotherapeutic intervention protocols.
Trial locations and contacts
1 site in 1 country.
Erica M Mancera-Soto, Therapist contact
Colombia1 site, 1 recruiting
- Recruiting
National university of Colombia
Bogotá, Cundinamarca, 110821
Wilder A Villamil-Parra, Therapist, (57)3017564038, wavillamilp@unal.edu.co
Erica M Mancera-Soto, Therapist, emmanceras@unal.edu.co
About this study
Official title: Effects of a Physical Exercise Program on the Responses Measured by HIF-1 Related to Ventilatory and Hematological Function in Patients With COPD Resident at 2600 m.s.n.m.
Despite being considered a potentially preventable disease, COPD is classified as one of the respiratory problems with the highest prevalence and socioeconomic impact. According to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), people with COPD require actions that optimize quality of life by improving lung function and increasing tolerance to fatigue.
Research such as those carried out by Semenza, establish that metazoan organisms such as the human species present biomolecular mechanisms for O2 homeostasis, based on transcriptional changes that allow regulating or modifying the responses necessary for the maintenance of the cellular metabolic functions. Hypoxia Induced Factor 1 (HIF-1) is the primary molecular mechanism for the regulation of O2-regulated genes in nuclear cells; Therefore, they promote adaptive mechanisms to hypoxia, through the generation of protein synthesis that favor processes such as erythropoiesis, angiogenesis, changes in oxidative metabolism and modification of the pulmonary vascular response.
Read more
Research carried out in cells of people with COPD exposed to environmental hypoxia by low oxygen pressure (PO2), have shown changes in the nuclear concentrations of HIF-1, affecting the transcriptional mechanisms of specific genes for Erythropoietin (EPO), the Factor of Vascular Endothelial Growth (VEFG) and therefore limit the generation of essential proteins for systemic responses. These transcriptional mechanisms are conditioned by the structural changes of chromatin seconded by the inhibition in the performance of histone enzymes, which influences the synthesis of proteins involved in metabolic, hematological and / or ventilatory processes as a response. to hypoxia. However, the concentration and effect of HIF 1 on the synthesis of EPO and VEGF and its relationship with spirometric and hematological tests have not been studied in COPD people who live in medium altitudes and who are additionally exposed to additional hypoxic stimuli such as exercise physical.
Although it is known that in COPD there is a decrease in the diffusion of O2 through the blood-gas barrier generating hypoxia and that with low PO2 there are biomolecular adaptations to favor oxygenation, perfusion, and metabolism; At the moment, the responses of HIF-1 and its effect on the generation of proteins associated with erythropoiesis and angiogenesis (EPO, FEVG) in people with COPD with physical exercise-based treatments are unknown.
Read the detailed description
- General objective To determine the effect of a physical exercise program on the responses mediated by HIF-1 in COPD patients resident at 2600 m.s.n.n.
- Research question. What is the effect of a physical exercise program on the responses mediated by HIF-1 in COPD patients resident at 2600 m.s.n.n?
- Type of study. It is presented as a quasi-experimental study with intra- and inter-group comparison before and after, with an external control group. Two observations will be made in time (pre and post test); Comparisons will be made intra-group and between groups, as follows: Experimental group 1:
- G1: People with a diagnosis of COPD stratified in GOLD 1-2.
- O1: Measurement of HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O2: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram. Experimental group 2:
- G2: People with a diagnosis of COPD stratified in GOLD 3-4.
- O3: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O4: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram. Control group:
- G3: People without a COPD diagnosis.
- O5: Measurement of HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O6: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- Phases of the study Phase 1. Enrollment of participants and identification of baselines of HIF-1 measurements, synthesis of VEGF and EPO, Spirometry and Hemogram. Phase 2. Piloting and application of the physical exercise program in COPD residents in medium altitudes. Phase 3. Final measurement of HIF-1, synthesis of VEGF and EPO, Spirometry and Hemogram; Phase 4. Analysis of intra and intergroup results, writing final research report, socialization and publication of results. The pilot test will be carried out with 10% of the initial sample calculated, in order to evaluate and refine the instruments to be used, verify the conditions of application of these and the procedures involved in obtaining the data, such as the times of registration of participants' participation in each session, execution of the physical exercise program and application of measurement tests.
- Sample size. A sample size calculation will be performed for longitudinal studies, using the Diggle formula for both differences between individuals and between groups, taking as a reference an expected effect, differences of 7.1, 4.96, 1.14 and 0.19 for the HIF-1; 1.6, 1.1; and finally 0.6, 0.3, 0.23 and 0.052 for the effect on VEGF and EPO protein synthesis. Similarly, variances (δ2) between 0.00004489 to 6.76 were considered depending on each effect measure as reported in the literature, Table 3 shows the expected variances and effect magnitudes in detail. Additionally, two measurements (pre and post) will be considered, for one (n = 4) for three comparison groups, with a type I error of α = 0.05, power P = 0.80 and exploring correlations (ρ) between -0.86 , 0.4, 0.47, 0.6, 0.79 or 0.8 depending on each parameter. Below, you can see the different scenarios where the study sample is sufficient, it is thus that for the value of the expected effect magnitude in each of the response variables with the different scenarios of variances and correlations raised, the sample can be between 1 to 2630 participants. For the consideration of the present study, a sample of 27 participants will be taken in order to be able to observe different magnitudes with sufficient power. Because there may be losses to follow-up, a 20% increase was made for a total of 33 participants, 11 per group (66 total measurements).
- Selection and enrollment of participants. After obtaining the endorsements of the research and ethics committees of the National University of Colombia, the study population will be called; This will be done in person and via telephone to potential participants of the research project. The call mechanism will be by: 1. Lists of people attending rehabilitation programs of hospital institutions, 2. Open invitation to possible participants, through radio calls, newspapers and social networks, 3. Direct invitation to known people who comply with the inclusion criteria. Once the invitation is made, a screening will be carried out to identify the inclusion and exclusion criteria; Next, an appointment will be scheduled with the participant to fill out the informed consent.
- Evaluation of the health condition and assignment of study groups. People interested in participating in the research and who have signed informed consent, will be initially summoned for the medical and therapeutic evaluation of their health condition, therefore a clinical history format is presented for this project (Annex 3); At this time, spirometry will be applied to determine the degree of pulmonary compromise according to what is presented by the GOLD report 2019. Additionally, the physical fitness of the participants will be measured for the prescription of physical exercise.
- Data analysis 8.1. Descriptive analysis For the descriptive analysis of the characteristics of the population studied, the variables on the qualitative measurement scale will be described as proportional frequencies, the continuous variables will be described with measures of central tendency (mean and median) and dispersion (standard deviation, interquartile range). according to whether or not they present a normal distribution according to graphic (histograms, dispersion, among others) and numerical (Shapiro-Wilk) methods. 8.2 Baseline analysis To compare the three groups (G1: COPD 1-2, G2: COPD 3-4, G3: without COPD). Parametric and non-parametric tests will be carried out according to the verification of a priori criteria. For comparisons between proportions, Chi2 or Fischer's exact will be carried out, for the comparison of continuous variables between the three groups an ANOVA or kruskal wallis test will be used. 8.3 Multivariate analysis As a longitudinal method, a repeated measures analysis will be carried out for correlated data. For each of the continuous outcome variables, the analysis will be performed with fixed effects (marginal) models. The evaluation of the assumption of normal distribution of the variables will be carried out using graphic methods (histograms, box plots and QQ graphs). In the model, the main exposure will be included as covariates, referring to the group it belongs to (G1: COPD 1-2, G2: COPD 3-4, G3: without COPD). The time will be taken as a continuous variable according to the minutes between each of the measurements, for which its linearity and its interactions with the covariates of interest will be evaluated, in case of not complying with this assumption it will be categorized based on the measurements carried out, considering the baseline measurement as a reference and the evaluation of possible interaction terms will be carried out. For the variables with normal distribution, the restrictive model of maximum likelihood (REML) will be used to select the best correlation matrix; later, to select the covariates to keep in the model, the maximum likelihood estimate (MLE) will be used. The selection of the best model will be based on the lower value of the Akaike information criterion (AIC) and the Bayesian evaluation criterion (BIC) after having evaluated the interactions and the non-linear terms. For conditional models, models with intercept and slopes will be used. If it does not present a normal distribution, a generalized equation estimation model (GEE) with an unstructured matrix will be implemented. A residual analysis will be performed on all final models. With the above, it will be possible to evaluate the effects both within and between groups with a more robust model to analyze the outcome measures and control for possible confounding variables.
- Intervention (Physical exercise program for people with COPD.) The physical exercise program is proposed according to the existing scientific evidence and the recommendations of the GOLD 2019. This program will be based on an 8-week macro training cycle with 3 sessions per week for a total of 24 out-of-hospital training sessions. It will consist of 4 steps, each one consisting of 2 training microcycles or 6 work sessions; Training of conditional and coordinative physical qualities will be carried out in each step, and additionally with health education sessions.
- Control of biases
10.1. Control and management of internal invalidation sources
- Threat-History. Actions to be taken: Participants in the experimental groups experience the same event, being people with COPD exposed to altitude hypoxia due to being residents at 2060 meters above sea level, with stratification of disease severity (GOLD 3 - 4).
- Threat - Maturation. Actions to be taken: Establishment of inclusion and exclusion criteria. Participants over 40 years of age with complete biological maturation.
- Threat-Instability of the measuring instrument. Actions to be taken: The instruments to be used in the collection of information have validity and reliability; They have been used in multiple investigations related to the subject and are strategies.
- Threat-Instability of the experimental environment. Actions to be carried out: the environmental conditions are the same for all the research participants since they will be applied at 2,600 meters above sea level in the city of Bogotá D.C. The intervention has a defined protocol that will be applied by the same researcher to all study participants.
- Threat: Instrumentation. Actions to be taken: the same measurement instruments will be applied to all research participants regardless of the stratification of the disease or the assignment to the control group.
- Threat - Selection. Actions to be taken: Participants will be established in groups according to the GOLD 3 or GOLD 4 disease stratification.
- Threat-attrition. Actions to be taken: Calculation of the sufficient sample size and carried out by a statistician outside the investigation, taking into account 20% of possible attrition.
10.2 Control and management of sources of external invalidation
- Threat-Reactive or interaction effect of the tests. Actions to be taken: The instruments that will be used in the collection of information have validity and reliability.
- Threat-Effect of interaction between selection errors and experimental treatment. Actions to be taken: Inclusion and exclusion criteria are established, which rule out people with aspects that can be inferred from the research results.
- Threat-Interference from multiple treatments. Actions to be taken: A single physical exercise program will be carried out for all the research participants.
- Threat: Impossibility of replicating the treatments: Actions to be taken: Detailed description of the content of the physical exercise program.
- Threat-Interaction between history or place and the effects of the experimental treatment. Actions to be carried out: The investigation will be carried out in the same place and laboratory, located at 2,600 meters above sea level, in the city of Bogotá D.C.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Physical exercise program, Health education in COPD
- Keywords
- Exercise, Hypoxia, Epigenomics, Therapeutics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programOther
Also called Therapeutic exercise
Step 1 • Diaphragmatic reeducation: • Aerobic capacity: Intensity: zone 2, 60% HRMax, 4-6 / 10 Borg Scale; Charge: 20 m.
Step 2 • Aerobic capacity: Intensity: zone 2, 65% HRMax, 4-6 Borg Scale; Charge: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 3-4 / 10 Omni-Res; Load: 20% 1RM; Series: 3; Reps: 1. • Flexibility and elasticity: Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s.
Step 3 • Aerobic capacity: Intensity: zone 3, 70% HRMax, 5-6 / 10 Borg scale, Load: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 4-5 / 10 Omni-Res; Load: 30% 1RM; Series: 4; Reps: 10. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s.
Step 4 •Aerobic capacity: Intensity: zone 3, 75% HRMax, 6-7 / 10 Borg scale, Load: 30 m. • Muscular strength: Intensity: 5-6 / 10 Omni-Res; Load: 40-50% 1RM; Series: 4 s; Reps: 13. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s.
Health education in COPDOther
Also called Health education
Week 1-2: Health education: COPD and respiratory care at home. Week 3-4: Importance of daily physical activity in COPD. Week 5-6: Early Signs of COPD Exacerbation and Action Plan Week 7-8: Use and care of respiratory devices at home.
| Study group | Role | What they receive |
|---|---|---|
| G1: People with a diagnosis of COPD stratified in GOLD 1-2. | Experimental | * Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years.
* People with a diagnosis of COPD categorized in GOLD 1-2, with no record of respiratory crises in the last 3 months.
* People with a diagnosis of COPD categorized by lung function in GOLD 1,2,3 and 4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen.
* People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l.
* People who have read and signed informed consent and who have membership in a mandatory health plan. Receives: Other: Physical exercise program; Other: Health education in COPD |
| G2: People with a diagnosis of COPD stratified in GOLD 3-4. | Experimental | * Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years.
* People with a diagnosis of COPD categorized in GOLD 1,2,3 and 4, with no record of respiratory crises in the last 3 months.
* People with a diagnosis of COPD categorized by lung function in GOLD 3-4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen.
* People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l.
* People who have read and signed informed consent and who have membership in a mandatory health plan. Receives: Other: Physical exercise program; Other: Health education in COPD |
| G3: Control - People without a COPD diagnosis. | Active comparator | Healthy people, over 40 years old. No history of cigarette smoking or exposure to wood smoke. Who do not present diagnoses of musculoskeletal injuries and who are residents at 2600 meters above sea level for more than 14 months. With affiliation to a mandatory health plan and signature of informed consent. Receives: Other: Physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nuclear concentration of HIF-1
Changes in the nuclear concentration of hypoxia-inducible factor (HIF-1) in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
VEGF protein synthesis.
Changes in the synthesis of the Vascular Endoletial Growth Factor (VEGF) protein in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Synthesis of EPO protein.
Changes in the synthesis of Erythropoietin (EPO) protein synthesis in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Secondary outcomes (13)
Arm Curl Test
The total number of times the dominant arm is flexed and extended during 30 seconds.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Chair Stand Test
The total number of times the person gets up and sits in the chair for 30 seconds.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
6 Minute WalK Test
Distance traveled by the person be walking on flat ground for 6 minutes
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Chair-Sit and Reach Test
While sitting, the person will touch the leg that is stretched out with their hands. The distance in cm from the tip of the fingers to the top of the shoe is measured while sitting. If the fingers of the hands do not reach the foot, the distance will be measured in negative values (-) and if the fingers of the hands exceed the foot, the distance will be recorded in positive values (+)
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Back Scratch Test
They put their hands touching their back "as if it were scratching." The distance between the tips of the middle fingers of the two hands. If the fingers of the hands do not touch, the distance will be measured in negative values (-). If the fingers of the hands overlap, the distance is recorded in positive values (+).
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
8-Foot up and go Test
The person gets up from the chair and walks as fast as possible by a line to surround a cone located 2.44 meters away and must sit again. The time (minutes and seconds) the person spends doing the exercise is measured.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Forced expired volume in the first second (FEV1)
Volume of air expelled during the first second of maximum expiration, carried out after maximum inspiration. Percentage of air expelled in the first second of expiration.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Functional Vital Capacity (FVC)
Maximum volume of expired air, with the maximum possible effort, starting from a maximum inspiration. It is expressed as a volume in milliliters.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
FEV1/FVC ratio
Relationship between Forced Expiratory Volume in the first second (FEV1) and Forced Vital Capacity (FVC). It is expressed as a percentage.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Erythrocyte count
Percentage of reticulocyte volume in a given volume of blood. Reticulocytes / blood volume * microliter.
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Medium corpuscular volume (MCV)
Average size of red blood cells. MCV(fl) = Hematocrit (%) x 10 / Red blood cells (x 10^6/ul)
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Mean Corpuscular Hemoglobin (HCM)
Average hemoglobin content of each red cell. HCM (pg) = Hemoglobin (g/dl) x 10/Red blood cells (x10^6/ul)
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Blood hemoglobin (Hb)
Amount of hemoglobin in blood sample expressed in grams per deciliter. Hb = g/dL
Measured: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study startJan 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental study with assignment to groups by convenience by severity of the disease. Group 1: COPD GOLD1-2, Group 2: COPD GOLD3-4, Group 3: Control. Study with intra- and inter-group comparison before and after intervention with an external control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Wilder A Villamil-Parra, Therapist, Principal investigator, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955977
- Sponsor's protocol ID
- 47970
- Acronym
- ECOPDHIF-1
- Status last verified
- Aug 2021
- First submitted
- 15 Jun 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment there are no plans to share data, since this process does not have the endorsement of the ethics committee.
Publications
Lee SW, Hwang HH, Hsu PW, Chuang TY, Liu CW, Wu LS. Whole-genome methylation profiling from PBMCs in acute-exacerbation COPD patients with good and poor responses to corticosteroid treatment. Genomics. 2019 Dec;111(6):1381-1386. doi: 10.1016/j.ygeno.2018.09.010. Epub 2018 Sep 21.
PubMed 30248490To M, Yamamura S, Akashi K, Charron CE, Haruki K, Barnes PJ, Ito K. Defect of adaptation to hypoxia in patients with COPD due to reduction of histone deacetylase 7. Chest. 2012 May;141(5):1233-1242. doi: 10.1378/chest.11-1536. Epub 2011 Dec 15.
PubMed 22172637Ito K, Ito M, Elliott WM, Cosio B, Caramori G, Kon OM, Barczyk A, Hayashi S, Adcock IM, Hogg JC, Barnes PJ. Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med. 2005 May 12;352(19):1967-76. doi: 10.1056/NEJMoa041892.
PubMed 15888697Semenza GL. Hypoxia-inducible factor 1 (HIF-1) pathway. Sci STKE. 2007 Oct 9;2007(407):cm8. doi: 10.1126/stke.4072007cm8.
PubMed 17925579Fu X, Zhang F. Role of the HIF-1 signaling pathway in chronic obstructive pulmonary disease. Exp Ther Med. 2018 Dec;16(6):4553-4561. doi: 10.3892/etm.2018.6785. Epub 2018 Sep 21.
PubMed 30542404Chen LJ, Xu W, Li YP, Ma LT, Zhang HF, Huang XB, Yu GG, Ma XQ, Chen C, Liu YH, Wu J, Wang LJ, Xu Y. Lycium barbarum Polysaccharide Inhibited Hypoxia-Inducible Factor 1 in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2020 Aug 24;15:1997-2004. doi: 10.2147/COPD.S254172. eCollection 2020.
PubMed 32921997Kanazawa H, Yoshikawa J. Elevated oxidative stress and reciprocal reduction of vascular endothelial growth factor levels with severity of COPD. Chest. 2005 Nov;128(5):3191-7. doi: 10.1378/chest.128.5.3191.
PubMed 16304261Tao H, Luo W, Pei H, Zhu S, Zhang M, Chen B, He J, Zhang M, Zhou R. [Expression and significance of hypoxia-inducible factor-1alpha in patients with chronic obstructive pulmonary disease and smokers with normal lung function]. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2014 Aug;30(8):852-5. Chinese.
PubMed 25108440Villamil-Parra W, Cristancho-Mejia E, Ramon Torrella J, Mancera-Soto EM. Effects of a physical exercise program on HIF-1alpha in people with Chronic Obstructive Pulmonary Disease living at high altitude: study protocol for a clinical trial. Trials. 2023 Oct 29;24(1):698. doi: 10.1186/s13063-023-07698-y.
PubMed 37899477
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Exercise Program on the Responses Measured by HIF-1 Related to Ventilatory and Hematological Function in Patients With COPD Resident at 2600 m.s.n.m.
- ClinicalTrials.gov ID
- NCT04955977
- Acronym / sponsor ID
- ECOPDHIF-1 / 47970
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Exercise, Hypoxia, Epigenomics, Therapeutics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- Jan 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite being considered a potentially preventable disease, COPD is classified as one of the respiratory problems with the highest prevalence and socioeconomic impact. According to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), people with COPD require actions that optimize quality of life by improving lung function and increasing tolerance to fatigue.
Research such as those carried out by Semenza, establish that metazoan organisms such as the human species present biomolecular mechanisms for O2 homeostasis, based on transcriptional changes that allow regulating or modifying the responses necessary for the maintenance of the cellular metabolic functions. Hypoxia Induced Factor 1 (HIF-1) is the primary molecular mechanism for the regulation of O2-regulated genes in nuclear cells; Therefore, they promote adaptive mechanisms to hypoxia, through the generation of protein synthesis that favor processes such as erythropoiesis, angiogenesis, changes in oxidative metabolism and modification of the pulmonary vascular response.
Research carried out in cells of people with COPD exposed to environmental hypoxia by low oxygen pressure (PO2), have shown changes in the nuclear concentrations of HIF-1, affecting the transcriptional mechanisms of specific genes for Erythropoietin (EPO), the Factor of Vascular Endothelial Growth (VEFG) and therefore limit the generation of essential proteins for systemic responses. These transcriptional mechanisms are conditioned by the structural changes of chromatin seconded by the inhibition in the performance of histone enzymes, which influences the synthesis of proteins involved in metabolic, hematological and / or ventilatory processes as a response. to hypoxia. However, the concentration and effect of HIF 1 on the synthesis of EPO and VEGF and its relationship with spirometric and hematological tests have not been studied in COPD people who live in medium altitudes and who are additionally exposed to additional hypoxic stimuli such as exercise physical.
Although it is known that in COPD there is a decrease in the diffusion of O2 through the blood-gas barrier generating hypoxia and that with low PO2 there are biomolecular adaptations to favor oxygenation, perfusion, and metabolism; At the moment, the responses of HIF-1 and its effect on the generation of proteins associated with erythropoiesis and angiogenesis (EPO, FEVG) in people with COPD with physical exercise-based treatments are unknown.
Detailed description
- General objective To determine the effect of a physical exercise program on the responses mediated by HIF-1 in COPD patients resident at 2600 m.s.n.n.
- Research question. What is the effect of a physical exercise program on the responses mediated by HIF-1 in COPD patients resident at 2600 m.s.n.n?
- Type of study. It is presented as a quasi-experimental study with intra- and inter-group comparison before and after, with an external control group. Two observations will be made in time (pre and post test); Comparisons will be made intra-group and between groups, as follows: Experimental group 1:
- G1: People with a diagnosis of COPD stratified in GOLD 1-2.
- O1: Measurement of HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O2: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram. Experimental group 2:
- G2: People with a diagnosis of COPD stratified in GOLD 3-4.
- O3: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O4: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram. Control group:
- G3: People without a COPD diagnosis.
- O5: Measurement of HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- X: Application of the physical exercise program.
- O6: Measurement HIF-1, HADC 7, EPO Synthesis, VGEF Synthesis, FEV1, Hemogram.
- Phases of the study Phase 1. Enrollment of participants and identification of baselines of HIF-1 measurements, synthesis of VEGF and EPO, Spirometry and Hemogram. Phase 2. Piloting and application of the physical exercise program in COPD residents in medium altitudes. Phase 3. Final measurement of HIF-1, synthesis of VEGF and EPO, Spirometry and Hemogram; Phase 4. Analysis of intra and intergroup results, writing final research report, socialization and publication of results. The pilot test will be carried out with 10% of the initial sample calculated, in order to evaluate and refine the instruments to be used, verify the conditions of application of these and the procedures involved in obtaining the data, such as the times of registration of participants' participation in each session, execution of the physical exercise program and application of measurement tests.
- Sample size. A sample size calculation will be performed for longitudinal studies, using the Diggle formula for both differences between individuals and between groups, taking as a reference an expected effect, differences of 7.1, 4.96, 1.14 and 0.19 for the HIF-1; 1.6, 1.1; and finally 0.6, 0.3, 0.23 and 0.052 for the effect on VEGF and EPO protein synthesis. Similarly, variances (δ2) between 0.00004489 to 6.76 were considered depending on each effect measure as reported in the literature, Table 3 shows the expected variances and effect magnitudes in detail. Additionally, two measurements (pre and post) will be considered, for one (n = 4) for three comparison groups, with a type I error of α = 0.05, power P = 0.80 and exploring correlations (ρ) between -0.86 , 0.4, 0.47, 0.6, 0.79 or 0.8 depending on each parameter. Below, you can see the different scenarios where the study sample is sufficient, it is thus that for the value of the expected effect magnitude in each of the response variables with the different scenarios of variances and correlations raised, the sample can be between 1 to 2630 participants. For the consideration of the present study, a sample of 27 participants will be taken in order to be able to observe different magnitudes with sufficient power. Because there may be losses to follow-up, a 20% increase was made for a total of 33 participants, 11 per group (66 total measurements).
- Selection and enrollment of participants. After obtaining the endorsements of the research and ethics committees of the National University of Colombia, the study population will be called; This will be done in person and via telephone to potential participants of the research project. The call mechanism will be by: 1. Lists of people attending rehabilitation programs of hospital institutions, 2. Open invitation to possible participants, through radio calls, newspapers and social networks, 3. Direct invitation to known people who comply with the inclusion criteria. Once the invitation is made, a screening will be carried out to identify the inclusion and exclusion criteria; Next, an appointment will be scheduled with the participant to fill out the informed consent.
- Evaluation of the health condition and assignment of study groups. People interested in participating in the research and who have signed informed consent, will be initially summoned for the medical and therapeutic evaluation of their health condition, therefore a clinical history format is presented for this project (Annex 3); At this time, spirometry will be applied to determine the degree of pulmonary compromise according to what is presented by the GOLD report 2019. Additionally, the physical fitness of the participants will be measured for the prescription of physical exercise.
- Data analysis 8.1. Descriptive analysis For the descriptive analysis of the characteristics of the population studied, the variables on the qualitative measurement scale will be described as proportional frequencies, the continuous variables will be described with measures of central tendency (mean and median) and dispersion (standard deviation, interquartile range). according to whether or not they present a normal distribution according to graphic (histograms, dispersion, among others) and numerical (Shapiro-Wilk) methods. 8.2 Baseline analysis To compare the three groups (G1: COPD 1-2, G2: COPD 3-4, G3: without COPD). Parametric and non-parametric tests will be carried out according to the verification of a priori criteria. For comparisons between proportions, Chi2 or Fischer's exact will be carried out, for the comparison of continuous variables between the three groups an ANOVA or kruskal wallis test will be used. 8.3 Multivariate analysis As a longitudinal method, a repeated measures analysis will be carried out for correlated data. For each of the continuous outcome variables, the analysis will be performed with fixed effects (marginal) models. The evaluation of the assumption of normal distribution of the variables will be carried out using graphic methods (histograms, box plots and QQ graphs). In the model, the main exposure will be included as covariates, referring to the group it belongs to (G1: COPD 1-2, G2: COPD 3-4, G3: without COPD). The time will be taken as a continuous variable according to the minutes between each of the measurements, for which its linearity and its interactions with the covariates of interest will be evaluated, in case of not complying with this assumption it will be categorized based on the measurements carried out, considering the baseline measurement as a reference and the evaluation of possible interaction terms will be carried out. For the variables with normal distribution, the restrictive model of maximum likelihood (REML) will be used to select the best correlation matrix; later, to select the covariates to keep in the model, the maximum likelihood estimate (MLE) will be used. The selection of the best model will be based on the lower value of the Akaike information criterion (AIC) and the Bayesian evaluation criterion (BIC) after having evaluated the interactions and the non-linear terms. For conditional models, models with intercept and slopes will be used. If it does not present a normal distribution, a generalized equation estimation model (GEE) with an unstructured matrix will be implemented. A residual analysis will be performed on all final models. With the above, it will be possible to evaluate the effects both within and between groups with a more robust model to analyze the outcome measures and control for possible confounding variables.
- Intervention (Physical exercise program for people with COPD.) The physical exercise program is proposed according to the existing scientific evidence and the recommendations of the GOLD 2019. This program will be based on an 8-week macro training cycle with 3 sessions per week for a total of 24 out-of-hospital training sessions. It will consist of 4 steps, each one consisting of 2 training microcycles or 6 work sessions; Training of conditional and coordinative physical qualities will be carried out in each step, and additionally with health education sessions.
- Control of biases
10.1. Control and management of internal invalidation sources
- Threat-History. Actions to be taken: Participants in the experimental groups experience the same event, being people with COPD exposed to altitude hypoxia due to being residents at 2060 meters above sea level, with stratification of disease severity (GOLD 3 - 4).
- Threat - Maturation. Actions to be taken: Establishment of inclusion and exclusion criteria. Participants over 40 years of age with complete biological maturation.
- Threat-Instability of the measuring instrument. Actions to be taken: The instruments to be used in the collection of information have validity and reliability; They have been used in multiple investigations related to the subject and are strategies.
- Threat-Instability of the experimental environment. Actions to be carried out: the environmental conditions are the same for all the research participants since they will be applied at 2,600 meters above sea level in the city of Bogotá D.C. The intervention has a defined protocol that will be applied by the same researcher to all study participants.
- Threat: Instrumentation. Actions to be taken: the same measurement instruments will be applied to all research participants regardless of the stratification of the disease or the assignment to the control group.
- Threat - Selection. Actions to be taken: Participants will be established in groups according to the GOLD 3 or GOLD 4 disease stratification.
- Threat-attrition. Actions to be taken: Calculation of the sufficient sample size and carried out by a statistician outside the investigation, taking into account 20% of possible attrition.
10.2 Control and management of sources of external invalidation
- Threat-Reactive or interaction effect of the tests. Actions to be taken: The instruments that will be used in the collection of information have validity and reliability.
- Threat-Effect of interaction between selection errors and experimental treatment. Actions to be taken: Inclusion and exclusion criteria are established, which rule out people with aspects that can be inferred from the research results.
- Threat-Interference from multiple treatments. Actions to be taken: A single physical exercise program will be carried out for all the research participants.
- Threat: Impossibility of replicating the treatments: Actions to be taken: Detailed description of the content of the physical exercise program.
- Threat-Interaction between history or place and the effects of the experimental treatment. Actions to be carried out: The investigation will be carried out in the same place and laboratory, located at 2,600 meters above sea level, in the city of Bogotá D.C.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Quasi-experimental study with assignment to groups by convenience by severity of the disease. Group 1: COPD GOLD1-2, Group 2: COPD GOLD3-4, Group 3: Control. Study with intra- and inter-group comparison before and after intervention with an external control group
| Arm | Type | Receives |
|---|---|---|
| G1: People with a diagnosis of COPD stratified in GOLD 1-2. | Experimental | Other: Physical exercise program, Other: Health education in COPD* Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years. * People with a diagnosis of COPD categorized in GOLD 1-2, with no record of respiratory crises in the last 3 months. * People with a diagnosis of COPD categorized by lung function in GOLD 1,2,3 and 4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen. * People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l. * People who have read and signed informed consent and who have membership in a mandatory health plan. |
| G2: People with a diagnosis of COPD stratified in GOLD 3-4. | Experimental | Other: Physical exercise program, Other: Health education in COPD* Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years. * People with a diagnosis of COPD categorized in GOLD 1,2,3 and 4, with no record of respiratory crises in the last 3 months. * People with a diagnosis of COPD categorized by lung function in GOLD 3-4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen. * People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l. * People who have read and signed informed consent and who have membership in a mandatory health plan. |
| G3: Control - People without a COPD diagnosis. | Active comparator | Other: Physical exercise programHealthy people, over 40 years old. No history of cigarette smoking or exposure to wood smoke. Who do not present diagnoses of musculoskeletal injuries and who are residents at 2600 meters above sea level for more than 14 months. With affiliation to a mandatory health plan and signature of informed consent. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult person, over 40 years of age, both sexes, resident in medium altitudes or 2,600 meters above sea level in the last 2 years.
- People with a diagnosis of COPD categorized in GOLD 1,2,3 and 4, with no record of respiratory crises in the last 3 months.
- People with a diagnosis of COPD categorized by lung function in GOLD 1,2,3 and 4 and by severity of symptoms in A, B and C, without the need for supplemental oxygen.
- People with a diagnosis of COPD settled and domiciled for a minimum time of 14 months at moderate altitudes or 2600 m.a.s.l.
- People who have read and signed informed consent and who have membership in a mandatory health plan.
Key exclusion criteria (7 listed)
- People with a medical diagnosis of anemia, liver disease, chronic kidney disease, rheumatological diseases or a history of gastrointestinal bleeding in the last 2 months.
- People with a diagnosis of COPD who have a history of kidney or liver transplantation.
- People with a diagnosis of COPD who present severity of symptoms and/or respiratory exacerbations categorized in D presenting an mMRC > 2 and CAT > 10 with >1 hospitalization requirements.
- People who are under pharmacological management with erythropoietin (EPO), antibiotics and / or steroids on a chronic basis.
- People with musculoskeletal injuries that limit the execution of the physical training program or that present medical restrictions for the execution of physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise programAlso: Therapeutic exerciseStep 1 • Diaphragmatic reeducation: • Aerobic capacity: Intensity: zone 2, 60% HRMax, 4-6 / 10 Borg Scale; Charge: 20 m. Step 2 • Aerobic capacity: Intensity: zone 2, 65% HRMax, 4-6 Borg Scale; Charge: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 3-4 / 10 Omni-Res; Load: 20% 1RM; Series: 3; Reps: 1. • Flexibility and elasticity: Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s. Step 3 • Aerobic capacity: Intensity: zone 3, 70% HRMax, 5-6 / 10 Borg scale, Load: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 4-5 / 10 Omni-Res; Load: 30% 1RM; Series: 4; Reps: 10. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s. Step 4 •Aerobic capacity: Intensity: zone 3, 75% HRMax, 6-7 / 10 Borg scale, Load: 30 m. • Muscular strength: Intensity: 5-6 / 10 Omni-Res; Load: 40-50% 1RM; Series: 4 s; Reps: 13. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s. | Other | G1: People with a diagnosis of COPD stratified in GOLD 1-2., G2: People with a diagnosis of COPD stratified in GOLD 3-4., G3: Control - People without a COPD diagnosis. |
| Health education in COPDAlso: Health educationWeek 1-2: Health education: COPD and respiratory care at home. Week 3-4: Importance of daily physical activity in COPD. Week 5-6: Early Signs of COPD Exacerbation and Action Plan Week 7-8: Use and care of respiratory devices at home. | Other | G1: People with a diagnosis of COPD stratified in GOLD 1-2., G2: People with a diagnosis of COPD stratified in GOLD 3-4. |
Primary outcome
Nuclear concentration of HIF-1
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Changes in the nuclear concentration of hypoxia-inducible factor (HIF-1) in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
VEGF protein synthesis.
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Changes in the synthesis of the Vascular Endoletial Growth Factor (VEGF) protein in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
Synthesis of EPO protein.
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Changes in the synthesis of Erythropoietin (EPO) protein synthesis in plasma. For this, an enzyme-linked immunosorbent assay (ELISA) will be executed using specific antibodies to immobilize the study proteins on a plate for their subsequent detection, with chemiluminescence detection.
13 secondary outcomes
Arm Curl Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Chair Stand Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
6 Minute WalK Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Chair-Sit and Reach Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Back Scratch Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
8-Foot up and go Test
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Forced expired volume in the first second (FEV1)
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Functional Vital Capacity (FVC)
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
FEV1/FVC ratio
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Erythrocyte count
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Medium corpuscular volume (MCV)
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Mean Corpuscular Hemoglobin (HCM)
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Blood hemoglobin (Hb)
Time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 30248490Lee SW, Hwang HH, Hsu PW, Chuang TY, Liu CW, Wu LS. Whole-genome methylation profiling from PBMCs in acute-exacerbation COPD patients with good and poor responses to corticosteroid treatment. Genomics. 2019 Dec;111(6):1381-1386. doi: 10.1016/j.ygeno.2018.09.010. Epub 2018 Sep 21.
- Background: PubMed 22172637To M, Yamamura S, Akashi K, Charron CE, Haruki K, Barnes PJ, Ito K. Defect of adaptation to hypoxia in patients with COPD due to reduction of histone deacetylase 7. Chest. 2012 May;141(5):1233-1242. doi: 10.1378/chest.11-1536. Epub 2011 Dec 15.
- Background: PubMed 15888697Ito K, Ito M, Elliott WM, Cosio B, Caramori G, Kon OM, Barczyk A, Hayashi S, Adcock IM, Hogg JC, Barnes PJ. Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med. 2005 May 12;352(19):1967-76. doi: 10.1056/NEJMoa041892.
- Background: PubMed 17925579Semenza GL. Hypoxia-inducible factor 1 (HIF-1) pathway. Sci STKE. 2007 Oct 9;2007(407):cm8. doi: 10.1126/stke.4072007cm8.
- Background: PubMed 30542404Fu X, Zhang F. Role of the HIF-1 signaling pathway in chronic obstructive pulmonary disease. Exp Ther Med. 2018 Dec;16(6):4553-4561. doi: 10.3892/etm.2018.6785. Epub 2018 Sep 21.
- Background: PubMed 32921997Chen LJ, Xu W, Li YP, Ma LT, Zhang HF, Huang XB, Yu GG, Ma XQ, Chen C, Liu YH, Wu J, Wang LJ, Xu Y. Lycium barbarum Polysaccharide Inhibited Hypoxia-Inducible Factor 1 in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2020 Aug 24;15:1997-2004. doi: 10.2147/COPD.S254172. eCollection 2020.
- Background: PubMed 16304261Kanazawa H, Yoshikawa J. Elevated oxidative stress and reciprocal reduction of vascular endothelial growth factor levels with severity of COPD. Chest. 2005 Nov;128(5):3191-7. doi: 10.1378/chest.128.5.3191.
- Results publication: PubMed 25108440Tao H, Luo W, Pei H, Zhu S, Zhang M, Chen B, He J, Zhang M, Zhou R. [Expression and significance of hypoxia-inducible factor-1alpha in patients with chronic obstructive pulmonary disease and smokers with normal lung function]. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2014 Aug;30(8):852-5. Chinese.
- Derived from this study: PubMed 37899477Villamil-Parra W, Cristancho-Mejia E, Ramon Torrella J, Mancera-Soto EM. Effects of a physical exercise program on HIF-1alpha in people with Chronic Obstructive Pulmonary Disease living at high altitude: study protocol for a clinical trial. Trials. 2023 Oct 29;24(1):698. doi: 10.1186/s13063-023-07698-y.
- Individual participant dataSharing planned: No. At the moment there are no plans to share data, since this process does not have the endorsement of the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica M Mancera-Soto, Therapist contact
Wilder A Villamil-Parra, Therapist principal investigator
Universidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise program and Health education in COPD in people with Pulmonary Disease, Chronic Obstructive, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilder A Villamil-Parra, Therapist ((57)3017564038, wavillamilp@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nuclear concentration of HIF-1 (time frame: 1. Initial measurement (week 0) before the application of the physical exercise program. 2. Final measurement (week 8) after completion of the intervention program.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955977, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.