Chronic Renal FailureNCT04525196
Physical Activity in Dialysis: Clinical and Biological Impact
A study testing Physical activity. in people with Chronic Renal Failure, run by Elsan at 2 sites in France.
Trial summary
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases. The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Physical activity.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jan 2021to 29 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 or over.
- Patient on hemodialysis.
- Patient in sufficient clinical condition allowing performing physical activity sessions during dialysis, according to the judgment of the investigator.
- Patient who was informed of the study and who gave his informed consent.
- Patient benefiting from a mandatory social security.
Who cannot join
- Recent myocardial infarction (<1 month).
- Rheumatological pathology which does not allow pedaling.
- Unmatched amputation of the lower limbs.
- Patients under legal protection.
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Clinique Bouchard
Marseille, 13006
Stanislas BATAILLE, MD
- Recruiting
Polyclinique les Fleurs
Ollioules, 83190
Valérie MASSON, MD
About this study
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases.
The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away.
Read more
Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients.
With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.
Read the detailed description
The health risk of a sedentary and inactive lifestyle is known in the general population, increasing the risk of diabetes (+ 25%), obesity, arterial hypertension, stroke, myocardial infarction and the development of certain cancers.
Sedentary lifestyle therefore decreases longevity and life expectancy by 5 and 8 years respectively.
At the same time, the benefits of physical activity (PA) are recognized (the list is not exhaustive):
- Factor for improving physical capacity,
- Preventive effect on many cardiovascular risk factors,
- Improvement of psychological well-being (anxiety, depression, stress, etc.),
- Cognitive functions, reduction in the rate of certain cancers (colon and breast mainly),
- Reduction of oxidative stress. The High Authority of Health (HAS) recognizes physical activity as a therapy on its own in the prevention of chronic diseases after having noticed the harmful effects of physical inactivity (PI) on life expectancy.
PI is believed to be responsible for 1.9 million deaths worldwide each year, increasing public health costs, estimated at 150-300 euros per year and per citizen.
The population of patients with Chronic Renal Failure (CRF) on dialysis has a low physical capacity, a low level of PA decreasing as the number of years of dialysis increases.
These parameters are correlated with mortality: a critical number of steps of less than 4000 per day, or activity less than 50 minutes per day without dialysis significantly worsens mortality.
The association between mortality and level of PA is linear and this linearity is maintained over time.
CRF and dialysis promote catabolic factors in metabolism, decline in muscle mass and strength to sarcopenia (associated with inflammation, hypoandrogenism, intakes of inadequate protein, metabolic acidosis, insulin resistance and inactivity).
The decline in physical performance promotes falls, fractures, loss of autonomy, the number of hospitalizations which indirectly increases public health costs.
Several studies have shown the benefit of developing a per-dialytic PA program providing benefits in quality of life, physical capacity, reduction of hypotension blood pressure, depression, and VO2 max. Resistance exercise also improves muscle mass and strength.
PA acts as a cardioprotector by lowering total cholesterol, triglycerides, improving blood pressure profile, and consequently reducing the number of cardiovascular events on a follow-up of 2 years.
Finally, the DOPPS 2009-2011 observational study demonstrates the link between the level of physical aerobic activity and the parallel decline in mortality.
In addition, peripheral vascular and arterial complications are common in patients with CRF and dialysis. The prevalence of symptomatic Obstructive Arterial Disease of the Lower Limbs is estimated between 20% and 25% but it reaches 40% in the Japanese study of Matsuzawa, and 70% if associating the numerous asymptomatic patients.
Associated with the aging of the population and increasing sedentary lifestyle, we are faced with the appearance of extremely serious ischemic trophic disorders, difficult to treat, despite taking appropriate medical, surgical and cicatricial load often resulting in amputation, deterioration of general condition, loss of independence, depression of wasting away.
There is also an increased risk of associated cardiovascular mortality even in asymptomatic patients. The more severe the arterial disease is, greater the risk is. Thus, patients with critical ischemia have a one-year mortality of 25%.
Despite the importance of these data, associated with the individual consequences following amputations, the medical interest in this pathology is relatively low, and there are only few studies in hemodialysis subjects.
Exercise, especially walking, is recommended for patients at the stage of intermittent claudication. A meta-analysis performed in the general population showed that gait training improved walking ability by 150%.
The main objective of this study is to assess the clinical benefit of a physical activity program in terms of performance on the 6-minute walk test.
One of the secondary objectives of this study will be to assess the impact of a PA program on the occurrence of Obstructive Arterial Disease of the Lower Limbs. The investigators want to check whether the implementation of a program of per-dialytic physical activity would improve the microcirculation of the lower limbs and reduce the complications of arteritis.
- Conditions
- Chronic Renal Failure
- Being tested
- Physical activity.
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity.Other
The procedure under study (physical activity program) will include, each week for 12 months, two sessions dedicated to the development of aerobic capacity and a muscle building session.
The experimental group will therefore be offered 3 sessions of Physical Activity (PA) per week. The PA will be positioned in the first two hours after the start of the dialysis session. Each session will include 5 minutes of general warm-up, then 15 minutes of PA itself and finally 5 minutes of cool down period. The PA time itself will be increased as the sessions progress, according to the progress and improvement of physical capabilities of patients.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity. | Experimental | Patients will benefit a physical activity program during their dialysis session. Receives: Other: Physical activity. |
| No physical activity. | No intervention | Patients will have access to their dialysis sessions without additional physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical impact of a physical activity program on the walking capacity.
Measure and evolution of the performance to the 6 minutes walking test.
Measured: Baseline.
The clinical impact of a physical activity program on the walking capacity.
Measure and evolution of the performance to the 6 minutes walking test.
Measured: 6 months after the inclusion.
Secondary outcomes (25)
The clinical impact of a 12 month physical activity program on the aeroby capacity of the patients.
Measure and evolution of the performance to the 6 minutes walking test.
Measured: At the randomization visit, and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Measure and evolution of the extension force of the lower limbs.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Measure and evolution of the extension force of the handgrip.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Measure and evolution of the extension force of the elbow flexion.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Measure and evolution of the extension force of the sit/stand up test.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the weight in kg.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the BMI in kg/m².
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the body surface given in m².
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the active cell mass in kg.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the muscle mass in kg.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the mass index lean in kg.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the albuminemia in g/L.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the pre-albuminemia in g/L.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the nPCR (Normalized Protein Catabolic Rate) in g/kg/day.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Measure and evolution of the creatinine in mmol/L.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the Obstructive Arterial Disease of the Lower Limbs.
Measure and evolution of the systolic pressure index and the systolic pressure of the toe measured by the SYSTOE, the number of revasularisations, the number of ischemic wounds, the number of amputations, and the number of deaths linked to the Obstructive Arterial Disease of the Lower Limbs.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact on a physical activity program on the biological parameters.
Measure and evolution of the hemoglobin in g/dl.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact on a physical activity program on the biological parameters.
Measure and evolution of the CRP in μg/mL.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact on a physical activity program on the biological parameters.
Measure and evolution of the PTH in pg/mL.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact of a physical activity program on the quality of life.
Evolution of the score obtained at the SF-36 questionnaire.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the survival.
Evolution of the vital status.
Measured: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact of a physical activity program on the the relationship between caregivers and patients, the creation of social ties and "coping" (the ability to cope and adapt in response to stress)
Evolution of the score obtained at the WCC-R questionnaire.
Measured: At the randomization visit, and 6 months after the inclusion.
The compliance with physical activity.
Development of aerobic capacity: the duration and, if applicable, the resistance level will be specified for each session.
Measured: After each physical activity session performed by the patient.
The compliance with physical activity.
Muscle strengthening: the number of repetitions performed and the resistance level will be specified for each session.
Measured: After each physical activity session performed by the patient.
The tolerance to physical activity.
Adverse events: collection of the frequency and severity. Collection of the adverse events related to the PA program (group experimental only).
Measured: 1 year, during each physical activity session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start29 Jan 2021
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Jul 2025 (estimated)
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 Chronic Renal FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525196
- Sponsor's protocol ID
- Dialyse
- Status last verified
- Oct 2023
- First submitted
- 29 Jul 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
PubMed 21177953Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111/j.1476-5381.2012.01970.x.
PubMed 22486393Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24. doi: 10.1111/j.1523-1755.2004.00411.x.
PubMed 14717947Kopple JD, Kim JC, Shapiro BB, Zhang M, Li Y, Porszasz J, Bross R, Feroze U, Upreti R, Kalantar-Zadeh K. Factors affecting daily physical activity and physical performance in maintenance dialysis patients. J Ren Nutr. 2015 Mar;25(2):217-22. doi: 10.1053/j.jrn.2014.10.017.
PubMed 25701942Panaye M, Kolko-Labadens A, Lasseur C, Paillasseur JL, Guillodo MP, Levannier M, Teta D, Fouque D. Phenotypes influencing low physical activity in maintenance dialysis. J Ren Nutr. 2015 Jan;25(1):31-9. doi: 10.1053/j.jrn.2014.07.010. Epub 2014 Oct 8.
PubMed 25304464Matsuzawa R, Roshanravan B, Shimoda T, Mamorita N, Yoneki K, Harada M, Watanabe T, Yoshida A, Takeuchi Y, Matsunaga A. Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. J Ren Nutr. 2018 Jan;28(1):45-53. doi: 10.1053/j.jrn.2017.07.004. Epub 2017 Sep 8.
PubMed 28893466Matsuzawa R, Matsunaga A, Wang G, Kutsuna T, Ishii A, Abe Y, Takagi Y, Yoshida A, Takahira N. Habitual physical activity measured by accelerometer and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol. 2012 Dec;7(12):2010-6. doi: 10.2215/CJN.03660412. Epub 2012 Sep 13.
PubMed 22977216Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.
PubMed 23124787Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7.
PubMed 24913219Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.
PubMed 27909047Olvera-Soto MG, Valdez-Ortiz R, Lopez Alvarenga JC, Espinosa-Cuevas Mde L. Effect of Resistance Exercises on the Indicators of Muscle Reserves and Handgrip Strength in Adult Patients on Hemodialysis. J Ren Nutr. 2016 Jan;26(1):53-60. doi: 10.1053/j.jrn.2015.06.006. Epub 2015 Aug 8.
PubMed 26264173Isnard-Rouchon M, Coutard C. [Exercise as a protective cardiovascular and metabolic factor in end stage renal disease patients]. Nephrol Ther. 2017 Dec;13(7):544-549. doi: 10.1016/j.nephro.2017.01.027. Epub 2017 Nov 7. French.
PubMed 29126841Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.
PubMed 25278548Matsuzawa R, Aoyama N, Yoshida A. Clinical Characteristics of Patients on Hemodialysis With Peripheral Arterial Disease. Angiology. 2015 Nov;66(10):911-7. doi: 10.1177/0003319715572678. Epub 2015 Feb 18.
PubMed 25694516Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.
PubMed 27851991
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Dialysis: Clinical and Biological Impact
- ClinicalTrials.gov ID
- NCT04525196
- Acronym / sponsor ID
- Dialyse
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 25 Aug 2020 (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.
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases.
The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away.
Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients.
With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.
Detailed description
The health risk of a sedentary and inactive lifestyle is known in the general population, increasing the risk of diabetes (+ 25%), obesity, arterial hypertension, stroke, myocardial infarction and the development of certain cancers.
Sedentary lifestyle therefore decreases longevity and life expectancy by 5 and 8 years respectively.
At the same time, the benefits of physical activity (PA) are recognized (the list is not exhaustive):
- Factor for improving physical capacity,
- Preventive effect on many cardiovascular risk factors,
- Improvement of psychological well-being (anxiety, depression, stress, etc.),
- Cognitive functions, reduction in the rate of certain cancers (colon and breast mainly),
- Reduction of oxidative stress. The High Authority of Health (HAS) recognizes physical activity as a therapy on its own in the prevention of chronic diseases after having noticed the harmful effects of physical inactivity (PI) on life expectancy.
PI is believed to be responsible for 1.9 million deaths worldwide each year, increasing public health costs, estimated at 150-300 euros per year and per citizen.
The population of patients with Chronic Renal Failure (CRF) on dialysis has a low physical capacity, a low level of PA decreasing as the number of years of dialysis increases.
These parameters are correlated with mortality: a critical number of steps of less than 4000 per day, or activity less than 50 minutes per day without dialysis significantly worsens mortality.
The association between mortality and level of PA is linear and this linearity is maintained over time.
CRF and dialysis promote catabolic factors in metabolism, decline in muscle mass and strength to sarcopenia (associated with inflammation, hypoandrogenism, intakes of inadequate protein, metabolic acidosis, insulin resistance and inactivity).
The decline in physical performance promotes falls, fractures, loss of autonomy, the number of hospitalizations which indirectly increases public health costs.
Several studies have shown the benefit of developing a per-dialytic PA program providing benefits in quality of life, physical capacity, reduction of hypotension blood pressure, depression, and VO2 max. Resistance exercise also improves muscle mass and strength.
PA acts as a cardioprotector by lowering total cholesterol, triglycerides, improving blood pressure profile, and consequently reducing the number of cardiovascular events on a follow-up of 2 years.
Finally, the DOPPS 2009-2011 observational study demonstrates the link between the level of physical aerobic activity and the parallel decline in mortality.
In addition, peripheral vascular and arterial complications are common in patients with CRF and dialysis. The prevalence of symptomatic Obstructive Arterial Disease of the Lower Limbs is estimated between 20% and 25% but it reaches 40% in the Japanese study of Matsuzawa, and 70% if associating the numerous asymptomatic patients.
Associated with the aging of the population and increasing sedentary lifestyle, we are faced with the appearance of extremely serious ischemic trophic disorders, difficult to treat, despite taking appropriate medical, surgical and cicatricial load often resulting in amputation, deterioration of general condition, loss of independence, depression of wasting away.
There is also an increased risk of associated cardiovascular mortality even in asymptomatic patients. The more severe the arterial disease is, greater the risk is. Thus, patients with critical ischemia have a one-year mortality of 25%.
Despite the importance of these data, associated with the individual consequences following amputations, the medical interest in this pathology is relatively low, and there are only few studies in hemodialysis subjects.
Exercise, especially walking, is recommended for patients at the stage of intermittent claudication. A meta-analysis performed in the general population showed that gait training improved walking ability by 150%.
The main objective of this study is to assess the clinical benefit of a physical activity program in terms of performance on the 6-minute walk test.
One of the secondary objectives of this study will be to assess the impact of a PA program on the occurrence of Obstructive Arterial Disease of the Lower Limbs. The investigators want to check whether the implementation of a program of per-dialytic physical activity would improve the microcirculation of the lower limbs and reduce the complications of arteritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity. | Experimental | Other: Physical activity.Patients will benefit a physical activity program during their dialysis session. |
| No physical activity. | No intervention | –Patients will have access to their dialysis sessions without additional physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 or over.
- Patient on hemodialysis.
- Patient in sufficient clinical condition allowing performing physical activity sessions during dialysis, according to the judgment of the investigator.
- Patient who was informed of the study and who gave his informed consent.
- Patient benefiting from a mandatory social security.
Key exclusion criteria (5 listed)
- Recent myocardial infarction (<1 month).
- Rheumatological pathology which does not allow pedaling.
- Unmatched amputation of the lower limbs.
- Patients under legal protection.
- Pregnant or breastfeeding women.
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 activity.The procedure under study (physical activity program) will include, each week for 12 months, two sessions dedicated to the development of aerobic capacity and a muscle building session. The experimental group will therefore be offered 3 sessions of Physical Activity (PA) per week. The PA will be positioned in the first two hours after the start of the dialysis session. Each session will include 5 minutes of general warm-up, then 15 minutes of PA itself and finally 5 minutes of cool down period. The PA time itself will be increased as the sessions progress, according to the progress and improvement of physical capabilities of patients. | Other | Physical activity. |
Primary outcome
The clinical impact of a physical activity program on the walking capacity.
Time frame: Baseline.
Measure and evolution of the performance to the 6 minutes walking test.
The clinical impact of a physical activity program on the walking capacity.
Time frame: 6 months after the inclusion.
Measure and evolution of the performance to the 6 minutes walking test.
25 secondary outcomes
The clinical impact of a 12 month physical activity program on the aeroby capacity of the patients.
Time frame: At the randomization visit, and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The clinical impact of a physical activity program on the muscle binding.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the nutritional status.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the Obstructive Arterial Disease of the Lower Limbs.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact on a physical activity program on the biological parameters.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact on a physical activity program on the biological parameters.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact on a physical activity program on the biological parameters.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact of a physical activity program on the quality of life.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
The impact of a physical activity program on the survival.
Time frame: At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.
To assess the impact of a physical activity program on the the relationship between caregivers and patients, the creation of social ties and "coping" (the ability to cope and adapt in response to stress)
Time frame: At the randomization visit, and 6 months after the inclusion.
The compliance with physical activity.
Time frame: After each physical activity session performed by the patient.
The compliance with physical activity.
Time frame: After each physical activity session performed by the patient.
The tolerance to physical activity.
Time frame: 1 year, during each physical activity session.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 21177953Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
- Background: PubMed 22486393Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111/j.1476-5381.2012.01970.x.
- Background: PubMed 14717947Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24. doi: 10.1111/j.1523-1755.2004.00411.x.
- Background: PubMed 25701942Kopple JD, Kim JC, Shapiro BB, Zhang M, Li Y, Porszasz J, Bross R, Feroze U, Upreti R, Kalantar-Zadeh K. Factors affecting daily physical activity and physical performance in maintenance dialysis patients. J Ren Nutr. 2015 Mar;25(2):217-22. doi: 10.1053/j.jrn.2014.10.017.
- Background: PubMed 25304464Panaye M, Kolko-Labadens A, Lasseur C, Paillasseur JL, Guillodo MP, Levannier M, Teta D, Fouque D. Phenotypes influencing low physical activity in maintenance dialysis. J Ren Nutr. 2015 Jan;25(1):31-9. doi: 10.1053/j.jrn.2014.07.010. Epub 2014 Oct 8.
- Background: PubMed 28893466Matsuzawa R, Roshanravan B, Shimoda T, Mamorita N, Yoneki K, Harada M, Watanabe T, Yoshida A, Takeuchi Y, Matsunaga A. Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. J Ren Nutr. 2018 Jan;28(1):45-53. doi: 10.1053/j.jrn.2017.07.004. Epub 2017 Sep 8.
- Background: PubMed 22977216Matsuzawa R, Matsunaga A, Wang G, Kutsuna T, Ishii A, Abe Y, Takagi Y, Yoshida A, Takahira N. Habitual physical activity measured by accelerometer and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol. 2012 Dec;7(12):2010-6. doi: 10.2215/CJN.03660412. Epub 2012 Sep 13.
- Background: PubMed 23124787Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.
- Background: PubMed 24913219Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7.
- Background: PubMed 27909047Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.
- Background: PubMed 26264173Olvera-Soto MG, Valdez-Ortiz R, Lopez Alvarenga JC, Espinosa-Cuevas Mde L. Effect of Resistance Exercises on the Indicators of Muscle Reserves and Handgrip Strength in Adult Patients on Hemodialysis. J Ren Nutr. 2016 Jan;26(1):53-60. doi: 10.1053/j.jrn.2015.06.006. Epub 2015 Aug 8.
- Background: PubMed 29126841Isnard-Rouchon M, Coutard C. [Exercise as a protective cardiovascular and metabolic factor in end stage renal disease patients]. Nephrol Ther. 2017 Dec;13(7):544-549. doi: 10.1016/j.nephro.2017.01.027. Epub 2017 Nov 7. French.
- Individual participant dataSharing planned: No
Related trials for Chronic Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity. in people with Chronic Renal Failure, run by Elsan at 2 sites in France.
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 5 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Valérie Masson, MD ((0)6 13 62 66 23 ext. +33, vmasson.nephro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical impact of a physical activity program on the walking capacity. (time frame: Baseline.). The study lists 2 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 NCT04525196, 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 19 Oct 2023.