Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients (DIALEX)

March 17, 2021 updated by: University Hospital, Montpellier

Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients: a Comparative Study of Current Practices.

Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

  • France
      • Montpellier, France, 34290
        • Uhmontpellier

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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients of Montpellier AIDER Santé dialysis center

Description

Inclusion criteria:

  • Hemodialysis started since at least 3 months
  • Medical prescription of perdialytic combined exercise
  • Age < 85
  • Life expectancy > 6 months

Exclusion criteria:

  • Ischemic and valvular cardiopathies
  • Lower-extremity arterial disease (stade III and IV)
  • Knee or hip amputation/prothesis
  • Severe respiratory disease
  • BMI > 35
  • Pacemaker

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Continuous
Other: Combined rehabilitation during hemodialysis
Combined rehabilitation during hemodialysis
Discontinuous
Other: Combined rehabilitation during hemodialysis
Combined rehabilitation during hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical
Time Frame: Week 0, week 17
Short Physical Performance Battery Score
Week 0, week 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee extension force
Time Frame: 1 day
Knee extension force
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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)

August 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0403

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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