Long Term Physical Activity for Hemodialysis Patients

NCT02860312 | Unknown DMC

• 2 other identifiers: AURASID-RCB 2015-A0031-48
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients on chronic hemodialysis present severe physical dysfunctioning associated with a significant reduction of their muscle mass. These two parameters are associated with increased morbidity and mortality along with deconditioning and poor quality of life. There are several studies- usually short term, single center uncontrolled and underpowered- that have shown a significant improvement of the physical, metabolic and dialytic parameters. There are only few studies that have measured the impact of a long term intradialytic exercise intervention on a supervised manner. This is a multi-center controlled study examining the effects of intradialytic cycling on parameters of physical functioning, body composition, cardiovascular and nutritional status, immunological status and quality of life in a group of clinically stable hemodialysis patients

Conditions

End Stage Renal Disease on Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Improvement of the distance covered after walking for 6 minutes (6 minutes walk test)

  The principal aim of the present study is to show the efficacy of intradialytic physical activity on the improvement of the physical capacity of the patients assessed with the 6 minutes walk test ((6MWT)

  12 months

Secondary Outcomes (29)

• Quality of life parameters 1

  12 months

• Quality of life parameters 2

  12 months

• Quality of life parameters 3

  12 months

• Physical activity levels

  12 months

• Body composition

  12 months

Study Arms (2)

Exercisers

ACTIVE COMPARATOR

Intradialytic exercise on stationary bicycles

Behavioral: Intradialytic exercise on stationary bicycles

Non Exercisers

PLACEBO COMPARATOR

No intradialytic exercise

Behavioral: Non-exercising group

Interventions

Intradialytic exercise on stationary bicycles BEHAVIORAL

Patients are exercising for 30-60 min during dialysis on an Rated Perceived Exertion (RPE) Scale between 12 and 14

Exercisers

Non-exercising group BEHAVIORAL

Patients are having their usual physical activity

Non Exercisers

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting active hemodialysis patients since at least 6 months aged between 20 and 90 y.o.

You may not qualify if:

• Unstable angina,
• severe left ventricular dysfunction,
• Ejection fraction \< 30%,
• severe peripheral arterial disease,
• lower extremity amputation,
• impossibility of physical effort: pain, uncontrolled bone/muscular disease,
• participation on another study.

Sponsors & Collaborators

• AURA Sante: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 9, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: May 1, 2019
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share