Patient AdherenceNCT05204498
Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With COPD
A study testing Education plan and adherence to exercise in people with Patient Adherence, run by Clínica de Occidente S.A at 1 site in Colombia.
Trial summary
Chronic obstructive pulmonary disease is one of the main causes of morbidity and mortality worldwide, according to recent publications of the World Health Organization, its main feature is the response to noxious particles of gases, which trigger an inflammatory response with its sequence secondary to the flow of air… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Patient Adherence
- What is being tested?
- Education plan and adherence to exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteColombia
- Study dates
- 10 May 2019to 25 Dec 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically stable
- Optimised medical therapy
- Patients who perform pulmonary rehabilitation for the first time
- Postbronchodilator FEV1 < 60% pred and FEV1/forced vital capacity (FVC) < 70% whithout significant reversibility (< 15% change un unutial FEV1)
Who cannot join
- Clinical evidence of exercise limiting cardiovascular
- Clinical evidence of neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Education Plan and Follow-up of Exercise Compliance in Patients With COPD Evaluated Through Knowledge of the Disease With the LINQ Questionnaire and Quality of Life With SGRQ Questionnaire
Chronic obstructive pulmonary disease is one of the main causes of morbidity and mortality worldwide, according to recent publications of the World Health Organization, its main feature is the response to noxious particles of gases, which trigger an inflammatory response with its sequence secondary to the flow of air, the limitation generated by the ventilation reserve mechanism of insufficiency, dyspnea and dysfunction at the muscular level, these limitations generate a high degree of disability worldwide in the different areas of the people who suffer from it, which it affects their basic performance and their interaction with the environment.
The World Health Organization, in a more recent projection, predicted that COPD will increase from its recent classification as the fifth most common cause of mortality to the fourth most common cause by 2030, which would place it behind ischemic cerebrovascular disease, HIV / AIDS and heart disease. More importantly, COPD is a cause that increases chronic disability and is expected to become the fifth most common cause of chronic disability worldwide by 2020.
Read more
There is great evidence on the benefit of pulmonary rehabilitation in patients with COPD, which generates changes among which is tolerance to exercise, dyspnea, control of symptoms and improvement in the quality of life related to health. It should be noted that pulmonary rehabilitation not only includes physical training, but also involves the educational component in relation to healthy habits. In this way, patients who have achieved a successful form of a pulmonary rehabilitation program must obtain an improvement in their physical and psychological state, following up on this type of patients, achieving the empowerment of the health process and improving long-term symptoms and healthy lifestyle habits.
Therefore, the objective of this study is to carry out a telephone education and a follow-up plan that emphasizes the importance of physical activity with adequate parameters to be part of the lifestyle of patients and to comply with the activity.
Read the detailed description
According to the population of the pulmonary rehabilitation center of the private IPS of Cali, it was analyzed by the program coordinator of the Pulmonary Rehabilitation Center.
If you consider that the patient is a candidate to enter the study, you can send an exam to be treated and you can be chosen. If the patient agrees to participate in the study, the knowledge approval process and the application of the clinical route, the basic information of the patient necessary to enter the study is collected.
Once signed, the patient undergoes a physical examination of their clinical and physical condition (Anthropometric parameters, Evaluation of dyspnea with modified scale of the Medical Research Council, Anxiety and Hospital Depression Scale, Saint George Respiratory Questionnaire, needs questionnaire of pulmonary information and 6 minutes walking test).
The walking test that was carried out following the parameters of the American Thoracic Society, in a linear corridor of 30 meters in length, could be used to walk down the corridor for 6 minutes in a row as quickly as possible, vital signs were taken. (blood pressure, heart rate and respiratory rate), oxygen saturation, fatigue in the lower extremities and dyspnea at the beginning and end of the test.
Allocation concealment: the questionnaires, the physical test, the anthropometric parameters were completed and the clinical survey was applied, the information was stored in a closed one and a serial number was assigned according to the order of the exercise. The envelopes were sent to the person responsible for the implementation of the tracking plan that was agreed with the order and the serial number was added to the database.
The randomization of the groups is done in a pre-established template in the following way: simple random sampling with Excel, to list is in the table of the study database and where the variables are collected, the reference number from 1 to 40 according to the number of patients requested to enter the study, apply to a simple randomization formula and a different Excel spreadsheet, up to number 20 (the amount corresponding to the whole follow-up group) B), the numbers that have the The results of this randomization are those assigned to the follow-up group.
In this way, when patients register in the database in the numerical order of the envelope, they are automatically assigned according to the randomization of the group to which the patient belongs (follow-up or control).
Once the patients have been included in the data collection and the variables, the patients belonging to the follow-up group have been submitted to the monitoring monitoring plan, since the activity must be recorded in an Excel table where the control was carried out. and record of it.
The patients attended three times a week, for one hour daily to the pulmonary rehabilitation program to complete a total of 24 sessions, during the sessions the calisthenics were performed, the strengthening of the lower limbs and the strengthening of the upper limbs, the respiratory exercises , continuous exercise for 30 minutes and group and individual educational component during 90 minutes a week, this time of education is in addition to the time of pulmonary rehabilitation.
Once the nursing assistant was responsible for the implementation of the follow-up plan of the process to carry out their activities as follows.
Check the number of patients entering the study, verify the date of admission and the end date, confirm that all patients have cell phones and landlines where they can be located.
She verified that the follow-up charts of each patient were completed, which was done twice a week for a total of 16 follow-ups or 8 weeks of the follow-up plan.
She makes 2 weekly phone calls, performs the days that patients do not attend pulmonary rehabilitation, calls are made with the schedule established in the work template or in the tracking record format.
In each monitoring chart for each patient, the call is recorded, with the recommendations made for patients to perform physical exercise and breathing exercises, the call lasts 15 minutes.
At the end of the 8-week study, Evaluation of Dyspnea with the Scale of the Modified Medical Research Council, The Escalation of Anxiety and Hospital Depression, The Problem of Abortion San Jorge, The Problem of Pulmonary Information Needs and the Walk Test 6 minutes at the Pulmonary Rehabilitation Center.
All the documentation that received the result of the study was guarded by the person in charge of the management of the database and the registry of variables.
The person in charge of the database and the registry of variables is the one who will inform when the study is finished. Subsequently, the information will be organized and the data will be delivered to the methodological advisor to organize, process and analyze the statistical information as a result.
- Conditions
- Patient Adherence
- Being tested
- Education plan and adherence to exercise
- Keywords
- chronic obstructive pulmonary disease, dyspnea, exercise tolerance, Education
- Medical subject headings
- Patient Compliance, Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education plan and adherence to exerciseBehavioural
Through phone calls with a motivating sense at any time of the day, twice a week.
- It will be recorded in an Excel table each time the patient is called.
- A monthly survey will be applied where the adherence to the exercise during the previous month is measured.
- These activities will be carried out for 8 weeks. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit to evaluate the anthropometric parameters, assess dyspnea with the modified scale of the Medical Research Council, the hospital anxiety and depression scale, the Saint George respiratory questionnaire , the pulmonary information You need the questionnaire and the 6-minute walk test again.
| Study group | Role | What they receive |
|---|---|---|
| Education plan | Experimental | Education plan and adherence to exercise Educational talk about the importance of exercise as an important strategy to change dyspnea at the start of the study.
Twice a week, corresponding to the days that do not attend the sessions of pulmonary rehabilitation, calls will be made with a duration of 15 minutes each, in the calls will encourage and guide the practice of physical activity and breathing exercises Receives: Behavioral: Education plan and adherence to exercise |
| control | No intervention | A survey will be conducted at week 8 of monitoring where adherence to exercise is measured during the 8-week study. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit in order to evaluate the anthropometric parameters, assess dyspnea with the modified Medical Research Council scale, the hospital anxiety and depression scale, the Saint George respiratory questionnaire, the pulmonary information needs questionnaire and the 6-minute walk test again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to exercise
practicing physical activity as a principle of self-determination and converting it into a healthy lifestyle or habit and aerobic capacity will be measured by completing 85% of sessions (21 sessions) of pulmonary rehabilitation, including education and telephone follow-up.
Measured: Measured at the end of the 8 week monitoring
knowledge of the disease
Faculty of the human being to understand the aspects related to his illness, the measurement of the needs in education will be carried out through the LINQ Lung Information Needs Questionnaire.
Measured: Measured at the end of the 8 week monitoring
health-related quality of life
A generic concept that reflects the concern for the modification and improvement of the attributes of life, for example, the physical, political, moral, social environment, as well as health and disease.
It is applied with the Saint George's Questionnaire (SGRQ), this scale goes from 0 to 100 points, high scores indicate that the patient is unwell and low scores the patient is better and a decrease of 4 points after an intervention is considered clinically significant.
Measured: Measured at the end of the 8 week monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start10 May 2019
- Primary completion25 Jul 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Patient AdherenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Occidente S.A
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Ávila, PT, Principal investigator, Clínica de Occidente S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204498
- Sponsor's protocol ID
- 0002
- Status last verified
- Nov 2021
- First submitted
- 10 Feb 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill K, Vogiatzis I, Burtin C. The importance of components of pulmonary rehabilitation, other than exercise training, in COPD. Eur Respir Rev. 2013 Sep 1;22(129):405-13. doi: 10.1183/09059180.00002913.
PubMed 23997066Ávila-Valencia, J. C., Muñoz-Erazo, B. E., Sarria, V., Cordoba, V. B., & Betancourt-Peña, J. (2017). Cambios en el Bode-Bodex de pacientes con EPOC al culminar un programa de rehabilitación pulmonar. Revista colombiana de rehabilitacion, 15(1), 40-47.
Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.
PubMed 12166558Mesquita R, Meijer K, Pitta F, Azcuna H, Goertz YMJ, Essers JMN, Wouters EFM, Spruit MA. Changes in physical activity and sedentary behaviour following pulmonary rehabilitation in patients with COPD. Respir Med. 2017 May;126:122-129. doi: 10.1016/j.rmed.2017.03.029. Epub 2017 Mar 31.
PubMed 28427543Naseer BA, Al-Shenqiti AM, Ali AH, Al-Jeraisi TM, Gunjan GG, Awaidallah MF. Effect of a short term pulmonary rehabilitation programme on exercise capacity, pulmonary function and health related quality of life in patients with COPD. J Taibah Univ Med Sci. 2017 Aug 23;12(6):471-476. doi: 10.1016/j.jtumed.2017.07.005. eCollection 2017 Dec.
PubMed 31435281Richards J, Hillsdon M, Thorogood M, Foster C. Face-to-face interventions for promoting physical activity. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD010392. doi: 10.1002/14651858.CD010392.pub2.
PubMed 24085592Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
PubMed 15674903Aznar S, Webster T. Actividad física y salud en la infancia y la adolescencia: Guía para todas las personas [Internet]. 2006. Available from: http://www.msssi.gob.es/ciudadanos/proteccionSalud/adultos/actiFisica/docs/ActividadFisicaSaludEspanol.pdf
Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based guidelines. ACCP/AACVPR Pulmonary Rehabilitation Guidelines Panel. American College of Chest Physicians. American Association of Cardiovascular and Pulmonary Rehabilitation. Chest. 1997 Nov 5;112(5):1363-96. No abstract available.
PubMed 9367481ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Médicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO
Gomez LF, Duperly J, Lucumi DI, Gamez R, Venegas AS. [Physical activity levels in adults living in Bogota (Colombia): prevalence and associated factors]. Gac Sanit. 2005 May-Jun;19(3):206-13. doi: 10.1157/13075953. Spanish.
PubMed 15960953Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.
PubMed 12160371Ilarraza-Lomeli H. [Cardiopulmonary exercise testing]. Arch Cardiol Mex. 2012 Apr-Jun;82(2):160-9. Spanish.
PubMed 22735657Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.
PubMed 9817683
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Education Plan and Follow-up of Exercise Compliance in Patients With COPD Evaluated Through Knowledge of the Disease With the LINQ Questionnaire and Quality of Life With SGRQ Questionnaire
- ClinicalTrials.gov ID
- NCT05204498
- Acronym / sponsor ID
- 0002
- Conditions
- Patient Adherence
- Keywords
- chronic obstructive pulmonary disease, dyspnea, exercise tolerance, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Clínica de Occidente S.AUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 24 Jan 2022 (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.
Chronic obstructive pulmonary disease is one of the main causes of morbidity and mortality worldwide, according to recent publications of the World Health Organization, its main feature is the response to noxious particles of gases, which trigger an inflammatory response with its sequence secondary to the flow of air, the limitation generated by the ventilation reserve mechanism of insufficiency, dyspnea and dysfunction at the muscular level, these limitations generate a high degree of disability worldwide in the different areas of the people who suffer from it, which it affects their basic performance and their interaction with the environment.
The World Health Organization, in a more recent projection, predicted that COPD will increase from its recent classification as the fifth most common cause of mortality to the fourth most common cause by 2030, which would place it behind ischemic cerebrovascular disease, HIV / AIDS and heart disease. More importantly, COPD is a cause that increases chronic disability and is expected to become the fifth most common cause of chronic disability worldwide by 2020.
There is great evidence on the benefit of pulmonary rehabilitation in patients with COPD, which generates changes among which is tolerance to exercise, dyspnea, control of symptoms and improvement in the quality of life related to health. It should be noted that pulmonary rehabilitation not only includes physical training, but also involves the educational component in relation to healthy habits. In this way, patients who have achieved a successful form of a pulmonary rehabilitation program must obtain an improvement in their physical and psychological state, following up on this type of patients, achieving the empowerment of the health process and improving long-term symptoms and healthy lifestyle habits.
Therefore, the objective of this study is to carry out a telephone education and a follow-up plan that emphasizes the importance of physical activity with adequate parameters to be part of the lifestyle of patients and to comply with the activity.
Detailed description
According to the population of the pulmonary rehabilitation center of the private IPS of Cali, it was analyzed by the program coordinator of the Pulmonary Rehabilitation Center.
If you consider that the patient is a candidate to enter the study, you can send an exam to be treated and you can be chosen. If the patient agrees to participate in the study, the knowledge approval process and the application of the clinical route, the basic information of the patient necessary to enter the study is collected.
Once signed, the patient undergoes a physical examination of their clinical and physical condition (Anthropometric parameters, Evaluation of dyspnea with modified scale of the Medical Research Council, Anxiety and Hospital Depression Scale, Saint George Respiratory Questionnaire, needs questionnaire of pulmonary information and 6 minutes walking test).
The walking test that was carried out following the parameters of the American Thoracic Society, in a linear corridor of 30 meters in length, could be used to walk down the corridor for 6 minutes in a row as quickly as possible, vital signs were taken. (blood pressure, heart rate and respiratory rate), oxygen saturation, fatigue in the lower extremities and dyspnea at the beginning and end of the test.
Allocation concealment: the questionnaires, the physical test, the anthropometric parameters were completed and the clinical survey was applied, the information was stored in a closed one and a serial number was assigned according to the order of the exercise. The envelopes were sent to the person responsible for the implementation of the tracking plan that was agreed with the order and the serial number was added to the database.
The randomization of the groups is done in a pre-established template in the following way: simple random sampling with Excel, to list is in the table of the study database and where the variables are collected, the reference number from 1 to 40 according to the number of patients requested to enter the study, apply to a simple randomization formula and a different Excel spreadsheet, up to number 20 (the amount corresponding to the whole follow-up group) B), the numbers that have the The results of this randomization are those assigned to the follow-up group.
In this way, when patients register in the database in the numerical order of the envelope, they are automatically assigned according to the randomization of the group to which the patient belongs (follow-up or control).
Once the patients have been included in the data collection and the variables, the patients belonging to the follow-up group have been submitted to the monitoring monitoring plan, since the activity must be recorded in an Excel table where the control was carried out. and record of it.
The patients attended three times a week, for one hour daily to the pulmonary rehabilitation program to complete a total of 24 sessions, during the sessions the calisthenics were performed, the strengthening of the lower limbs and the strengthening of the upper limbs, the respiratory exercises , continuous exercise for 30 minutes and group and individual educational component during 90 minutes a week, this time of education is in addition to the time of pulmonary rehabilitation.
Once the nursing assistant was responsible for the implementation of the follow-up plan of the process to carry out their activities as follows.
Check the number of patients entering the study, verify the date of admission and the end date, confirm that all patients have cell phones and landlines where they can be located.
She verified that the follow-up charts of each patient were completed, which was done twice a week for a total of 16 follow-ups or 8 weeks of the follow-up plan.
She makes 2 weekly phone calls, performs the days that patients do not attend pulmonary rehabilitation, calls are made with the schedule established in the work template or in the tracking record format.
In each monitoring chart for each patient, the call is recorded, with the recommendations made for patients to perform physical exercise and breathing exercises, the call lasts 15 minutes.
At the end of the 8-week study, Evaluation of Dyspnea with the Scale of the Modified Medical Research Council, The Escalation of Anxiety and Hospital Depression, The Problem of Abortion San Jorge, The Problem of Pulmonary Information Needs and the Walk Test 6 minutes at the Pulmonary Rehabilitation Center.
All the documentation that received the result of the study was guarded by the person in charge of the management of the database and the registry of variables.
The person in charge of the database and the registry of variables is the one who will inform when the study is finished. Subsequently, the information will be organized and the data will be delivered to the methodological advisor to organize, process and analyze the statistical information as a result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plan | Experimental | Behavioral: Education plan and adherence to exerciseEducation plan and adherence to exercise Educational talk about the importance of exercise as an important strategy to change dyspnea at the start of the study. Twice a week, corresponding to the days that do not attend the sessions of pulmonary rehabilitation, calls will be made with a duration of 15 minutes each, in the calls will encourage and guide the practice of physical activity and breathing exercises |
| control | No intervention | –A survey will be conducted at week 8 of monitoring where adherence to exercise is measured during the 8-week study. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit in order to evaluate the anthropometric parameters, assess dyspnea with the modified Medical Research Council scale, the hospital anxiety and depression scale, the Saint George respiratory questionnaire, the pulmonary information needs questionnaire and the 6-minute walk test again. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients clinically stable
- Optimised medical therapy
- Patients who perform pulmonary rehabilitation for the first time
- Postbronchodilator FEV1 < 60% pred and FEV1/forced vital capacity (FVC) < 70% whithout significant reversibility (< 15% change un unutial FEV1)
Key exclusion criteria (2 listed)
- Clinical evidence of exercise limiting cardiovascular
- Clinical evidence of neuromuscular diseases
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 |
|---|---|---|
| Education plan and adherence to exerciseThrough phone calls with a motivating sense at any time of the day, twice a week. * It will be recorded in an Excel table each time the patient is called. * A monthly survey will be applied where the adherence to the exercise during the previous month is measured. * These activities will be carried out for 8 weeks. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit to evaluate the anthropometric parameters, assess dyspnea with the modified scale of the Medical Research Council, the hospital anxiety and depression scale, the Saint George respiratory questionnaire , the pulmonary information You need the questionnaire and the 6-minute walk test again. | Behavioural | Education plan |
Primary outcome
Adherence to exercise
Time frame: Measured at the end of the 8 week monitoring
practicing physical activity as a principle of self-determination and converting it into a healthy lifestyle or habit and aerobic capacity will be measured by completing 85% of sessions (21 sessions) of pulmonary rehabilitation, including education and telephone follow-up.
knowledge of the disease
Time frame: Measured at the end of the 8 week monitoring
Faculty of the human being to understand the aspects related to his illness, the measurement of the needs in education will be carried out through the LINQ Lung Information Needs Questionnaire.
health-related quality of life
Time frame: Measured at the end of the 8 week monitoring
A generic concept that reflects the concern for the modification and improvement of the attributes of life, for example, the physical, political, moral, social environment, as well as health and disease. It is applied with the Saint George's Questionnaire (SGRQ), this scale goes from 0 to 100 points, high scores indicate that the patient is unwell and low scores the patient is better and a decrease of 4 points after an intervention is considered clinically significant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Background: PubMed 23997066Hill K, Vogiatzis I, Burtin C. The importance of components of pulmonary rehabilitation, other than exercise training, in COPD. Eur Respir Rev. 2013 Sep 1;22(129):405-13. doi: 10.1183/09059180.00002913.
- BackgroundÁvila-Valencia, J. C., Muñoz-Erazo, B. E., Sarria, V., Cordoba, V. B., & Betancourt-Peña, J. (2017). Cambios en el Bode-Bodex de pacientes con EPOC al culminar un programa de rehabilitación pulmonar. Revista colombiana de rehabilitacion, 15(1), 40-47.
- Background: PubMed 12166558Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.
- Background: PubMed 28427543Mesquita R, Meijer K, Pitta F, Azcuna H, Goertz YMJ, Essers JMN, Wouters EFM, Spruit MA. Changes in physical activity and sedentary behaviour following pulmonary rehabilitation in patients with COPD. Respir Med. 2017 May;126:122-129. doi: 10.1016/j.rmed.2017.03.029. Epub 2017 Mar 31.
- Background: PubMed 31435281Naseer BA, Al-Shenqiti AM, Ali AH, Al-Jeraisi TM, Gunjan GG, Awaidallah MF. Effect of a short term pulmonary rehabilitation programme on exercise capacity, pulmonary function and health related quality of life in patients with COPD. J Taibah Univ Med Sci. 2017 Aug 23;12(6):471-476. doi: 10.1016/j.jtumed.2017.07.005. eCollection 2017 Dec.
- Background: PubMed 24085592Richards J, Hillsdon M, Thorogood M, Foster C. Face-to-face interventions for promoting physical activity. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD010392. doi: 10.1002/14651858.CD010392.pub2.
- Background: PubMed 15674903Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
- BackgroundAznar S, Webster T. Actividad física y salud en la infancia y la adolescencia: Guía para todas las personas [Internet]. 2006. Available from: http://www.msssi.gob.es/ciudadanos/proteccionSalud/adultos/actiFisica/docs/ActividadFisicaSaludEspanol.pdf
- Background: PubMed 9367481Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based guidelines. ACCP/AACVPR Pulmonary Rehabilitation Guidelines Panel. American College of Chest Physicians. American Association of Cardiovascular and Pulmonary Rehabilitation. Chest. 1997 Nov 5;112(5):1363-96. No abstract available.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- BackgroundMédicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO
- Background: PubMed 15960953Gomez LF, Duperly J, Lucumi DI, Gamez R, Venegas AS. [Physical activity levels in adults living in Bogota (Colombia): prevalence and associated factors]. Gac Sanit. 2005 May-Jun;19(3):206-13. doi: 10.1157/13075953. Spanish.
- Individual participant dataSharing planned: No
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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.
Juan Ávila, PT principal investigator
Clínica de Occidente S.A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education plan and adherence to exercise in people with Patient Adherence, run by Clínica de Occidente S.A 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise (time frame: Measured at the end of the 8 week monitoring). 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 NCT05204498, which also lists 15 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 24 Jan 2022.