Chronic Renal InsufficiencyNCT06664385
Effect of a Concurrent Physical Exercise Program in Hemodialysis Patients
A study testing concurrent physical exercise in people with Chronic Renal Insufficiency and Hemodialysis, run by Pedro Julian Flores Moreno at 1 site in Mexico.
Trial summary
Concurrent physical exercise is the method of combining strength and endurance that can be worked with in one session or in an exercise program. Therefore, the researchers seek to implement it in patients suffering from chronic renal failure with hemodialysis therapy and see if concurrent physical exercise improves… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency, Hemodialysis
- What is being tested?
- concurrent physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 9 Aug 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are cared for at the State Hemodialysis Center.
- Receive hemodialysis treatment 3 times per week.
- Sign the informed consent form.
Who cannot join
- Patients under 18 years of age.
- Patients with a history of fracture at less than 2 months of evolution.
- Patients with any rheumatologic disease (lupus or rheumatoid arthritis).
- Prostrate patients.
- Amputee patients.
- Positive patients (HIV).
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- Uncontrolled comorbidities.
- Elimination.
- Patients who make their voluntary withdrawal from the project. Inability to engage in physical exercise.
- Death.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Estatal de Hemodialisis IMSS bienestar
Colima, Colima, 28060
About this study
Official title: Effect of a Concurrent Physical Exercise Program on Quality of Life in Hemodialysis Patients: Uncontrolled Clinical Trial
Concurrent physical exercise is the method of combining strength and endurance that can be worked with in one session or in an exercise program. Therefore, the researchers seek to implement it in patients suffering from chronic renal failure with hemodialysis therapy and see if concurrent physical exercise improves quality of life levels and at the same time see the response of physical fitness, body composition and biochemistry.
Read the detailed description
Introduction: The performance of physical exercise has positive effects in terms of quality of life, but when it is not performed consistently it triggers a sedentary lifestyle, which is reflected in overweight and obesity, in addition to developing chronic noncommunicable diseases, propitiating chronic kidney disease, which although, hereditary and environmental factors are also present in this pathology and as the disease progresses, chronic renal failure develops. Objective: To analyze the effect of a concurrent physical exercise program on quality of life in patients with chronic renal failure undergoing hemodialysis. Methods: Uncontrolled clinical trial in which a concurrent physical exercise program will be carried out for 6 weeks, performing physical evaluations such as 6-minute walk and manual strength by dynamometer, application of SF-36 questionnaires, measurement of urea, glucose, creatinine and albumin, in addition to analyzing body composition by electrical bioimpedance.
- Conditions
- Chronic Renal Insufficiency, Hemodialysis
- Being tested
- concurrent physical exercise
- Keywords
- Hemodialysis, Functional Capacity, physical exercise, Quality of life
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent physical exerciseOther
It consists of a periodization which consists of three moments adapted to the patient's needs distributed in 6 weeks and increasing the intensity gradually.
| Study group | Role | What they receive |
|---|---|---|
| concurrent physical exercise | Active comparator | It consists of an exercise method that combines strength and endurance. It has a duration of 6 weeks divided into three stages, adaptation, development and maintenance. That for the intervention group and for the control group will only be performing aerobic physical exercise according to their physical tolerance. Receives: Other: concurrent physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the level of quality of life with the SF-36 questionnaire, which ranges from 0 to 100 points, the higher the score, the higher the quality of life.
To analyze the quality of life of the patients and after the intervention to measure it again to see if the exercise has an impact on the levels of quality of life.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jul 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- non controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro Julian Flores Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- Fabián Rojas Larios, Israel Pérez Palafox, Luis Antonio Bermudez Aceves, Universidad de Colima
- Responsible party
- Sponsor-investigator, Pedro Julian Flores Moreno, Universidad de Colima
- Investigators
- Pedro J Flores, Doctor of Medical Sciences, Study chair, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664385
- Sponsor's protocol ID
- CEI 2024/1/CR/CL/SFIS/187
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the plan to share information with other researchers is through the publication of different articles that can be extracted from the research.
Publications
Molina-Robles E, Colomer-Codinachs M, Roquet-Bohils M, Chirveches-Perez E, Ortiz-Jurado P, Subirana-Casacuberta M. Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. Enferm Clin (Engl Ed). 2018 May-Jun;28(3):162-170. doi: 10.1016/j.enfcli.2017.12.003. Epub 2018 Mar 2. English, Spanish.
PubMed 29503041Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
PubMed 20098466
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Concurrent Physical Exercise Program on Quality of Life in Hemodialysis Patients: Uncontrolled Clinical Trial
- ClinicalTrials.gov ID
- NCT06664385
- Acronym / sponsor ID
- CEI 2024/1/CR/CL/SFIS/187
- Conditions
- Chronic Renal Insufficiency, Hemodialysis
- Keywords
- Hemodialysis, Functional Capacity, physical exercise, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pedro Julian Flores MorenoUniversity, hospital or other
- Collaborators
- Fabián Rojas Larios, Israel Pérez Palafox, Luis Antonio Bermudez Aceves, Universidad de Colima
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 29 Oct 2024 (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.
Concurrent physical exercise is the method of combining strength and endurance that can be worked with in one session or in an exercise program. Therefore, the researchers seek to implement it in patients suffering from chronic renal failure with hemodialysis therapy and see if concurrent physical exercise improves quality of life levels and at the same time see the response of physical fitness, body composition and biochemistry.
Detailed description
Introduction: The performance of physical exercise has positive effects in terms of quality of life, but when it is not performed consistently it triggers a sedentary lifestyle, which is reflected in overweight and obesity, in addition to developing chronic noncommunicable diseases, propitiating chronic kidney disease, which although, hereditary and environmental factors are also present in this pathology and as the disease progresses, chronic renal failure develops. Objective: To analyze the effect of a concurrent physical exercise program on quality of life in patients with chronic renal failure undergoing hemodialysis. Methods: Uncontrolled clinical trial in which a concurrent physical exercise program will be carried out for 6 weeks, performing physical evaluations such as 6-minute walk and manual strength by dynamometer, application of SF-36 questionnaires, measurement of urea, glucose, creatinine and albumin, in addition to analyzing body composition by electrical bioimpedance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| concurrent physical exercise | Active comparator | Other: concurrent physical exerciseIt consists of an exercise method that combines strength and endurance. It has a duration of 6 weeks divided into three stages, adaptation, development and maintenance. That for the intervention group and for the control group will only be performing aerobic physical exercise according to their physical tolerance. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are cared for at the State Hemodialysis Center.
- Receive hemodialysis treatment 3 times per week.
- Sign the informed consent form.
Key exclusion criteria (10 listed)
- Patients under 18 years of age.
- Patients with a history of fracture at less than 2 months of evolution.
- Patients with any rheumatologic disease (lupus or rheumatoid arthritis).
- Prostrate patients.
- Amputee patients.
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 |
|---|---|---|
| concurrent physical exerciseIt consists of a periodization which consists of three moments adapted to the patient's needs distributed in 6 weeks and increasing the intensity gradually. | Other | concurrent physical exercise |
Primary outcome
Comparison of the level of quality of life with the SF-36 questionnaire, which ranges from 0 to 100 points, the higher the score, the higher the quality of life.
Time frame: six weeks
To analyze the quality of life of the patients and after the intervention to measure it again to see if the exercise has an impact on the levels of quality of life.
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 31 Oct 2024.
- Background: PubMed 29503041Molina-Robles E, Colomer-Codinachs M, Roquet-Bohils M, Chirveches-Perez E, Ortiz-Jurado P, Subirana-Casacuberta M. Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. Enferm Clin (Engl Ed). 2018 May-Jun;28(3):162-170. doi: 10.1016/j.enfcli.2017.12.003. Epub 2018 Mar 2. English, Spanish.
- Background: PubMed 20098466Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
- Magazine containing extensive information on hemodialysis and physical exercise.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. the plan to share information with other researchers is through the publication of different articles that can be extracted from the research.
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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.
Pedro J Flores, Doctor of Medical Sciences study chair
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concurrent physical exercise in people with Chronic Renal Insufficiency and Hemodialysis, run by Pedro Julian Flores Moreno at 1 site in Mexico.
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 3 inclusion and 10 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 31 Oct 2024. 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 Mexico. 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?
Comparison of the level of quality of life with the SF-36 questionnaire, which ranges from 0 to 100 points, the higher the score, the higher the quality of life. (time frame: six weeks). 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 NCT06664385, which also lists 2 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 31 Oct 2024.