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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)

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ClinicalTrials.gov Identifier: NCT04538248
Recruitment Status : Completed
First Posted : September 4, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Hemodialysis Physical Rehabilitation Other: Combined rehabilitation during hemodialysis

Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Continuous
Continuous
 Other: Combined rehabilitation during hemodialysis
Combined rehabilitation during hemodialysis
Discontinuous
Discontinuous
 Other: Combined rehabilitation during hemodialysis
Combined rehabilitation during hemodialysis


Outcome Measures
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Primary Outcome Measures :
  1. Short Physical [ Time Frame: Week 0, week 17 ]
    Short Physical Performance Battery Score


Secondary Outcome Measures :
  1. Knee extension force [ Time Frame: 1 day ]
    Knee extension force


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients of Montpellier AIDER Santé dialysis center
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538248


Locations
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France
Uhmontpellier
Montpellier, France, 34290
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jean-Paul CRISTOL, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04538248    
Other Study ID Numbers: RECHMPL20_0403
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Perdialytic exercise
Combined rehabilitation
Functional abilities
Interference effect
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency