Physical Activity in Dialysis: Clinical and Biological Impact

October 18, 2023 updated by: Elsan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Marseille, France, 13006
        • Recruiting
        • Clinique Bouchard
        • Contact:
          • Stanislas BATAILLE, MD
      • Ollioules, France, 83190
        • Recruiting
        • Polyclinique Les Fleurs
        • Contact:
          • Valérie MASSON, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity.
Patients will benefit a physical activity program during their dialysis session.
Other: 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.
No Intervention: No physical activity.
Patients will have access to their dialysis sessions without additional physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline.
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.
6 months after the inclusion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measure and evolution of the performance to the 6 minutes walking test.
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.
Measure and evolution of the extension force of the lower limbs.
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.
Measure and evolution of the extension force of the handgrip.
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.
Measure and evolution of the extension force of the elbow flexion.
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.
Measure and evolution of the extension force of the sit/stand up test.
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.
Measure and evolution of the weight in kg.
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.
Measure and evolution of the BMI in kg/m².
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.
Measure and evolution of the body surface given in m².
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.
Measure and evolution of the active cell mass in kg.
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.
Measure and evolution of the muscle mass in kg.
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.
Measure and evolution of the mass index lean in kg.
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.
Measure and evolution of the albuminemia in g/L.
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.
Measure and evolution of the pre-albuminemia in g/L.
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.
Measure and evolution of the nPCR (Normalized Protein Catabolic Rate) in g/kg/day.
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.
Measure and evolution of the creatinine in mmol/L.
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.
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.
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.
Measure and evolution of the hemoglobin in g/dl.
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.
Measure and evolution of the CRP in μg/mL.
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.
Measure and evolution of the PTH in pg/mL.
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.
Evolution of the score obtained at the SF-36 questionnaire.
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.
Evolution of the vital status.
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.
Evolution of the score obtained at the WCC-R questionnaire.
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.
Development of aerobic capacity: the duration and, if applicable, the resistance level will be specified for each session.
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.
Muscle strengthening: the number of repetitions performed and the resistance level will be specified for each session.
After each physical activity session performed by the patient.
The tolerance to physical activity.
Time Frame: 1 year, during each physical activity session.
Adverse events: collection of the frequency and severity. Collection of the adverse events related to the PA program (group experimental only).
1 year, during each physical activity session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dialyse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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