Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

NCT02259413 | Completed DMC

• 1 other identifier: B2014:088
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether participation in a 26-week exercise rehabilitation program is effective at reducing symptom burden and improving quality of life in individuals receiving chronic hemodialysis.

Conditions

End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis

Keywords

Hemodialysis; End-stage renal disease; Exercise; Symptom Burden

Outcome Measures

Primary Outcomes (1)

• Change in dialysis symptom burden at 12 weeks

  Measured using change in the Dialysis Symptom Index

  Measured at study baseline and 12 weeks after study start

Secondary Outcomes (7)

• Change in dialysis symptom burden at 26 and 52 weeks

  Measured at study baseline, 26 and 52 weeks after study start

• Change in modified symptom burden

  Measured at study baseline, 12, 26 and 52 weeks after study start

• Change in health-related quality of life

  Measured at study baseline, 12, 26 and 52 weeks after study start

• Change in time for recovery post-dialysis

  Measured at study baseline, 12, 26 and 52 weeks after study start

• Change in endurance/exercise capacity

  Measured at study baseline, 12, 26 and 52 weeks after study start

Other Outcomes (3)

• Change in physical activity behaviour pattern

  Measured at study baseline, 12, 26 and 52 weeks after study start

• Hospitalization rate

  Measured at study baseline, 12, 26 and 52 weeks after study start

• Mortality

  Measured at 1 year after starting dialysis

Study Arms (2)

Exercise Rehabilitation

EXPERIMENTAL

Participants will receive baseline exercise counselling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components: 1. One-to-one self-management/resistance education once per week during the first 4 weeks of intervention. Participants will subsequently receive resistance training material to allow for home exercise for the remaining 22 weeks of the intervention. 2. Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions. 3. Four additional one-to-one standardized education sessions will be completed during the intervention period.

Behavioral: Exercise Rehabilitation

Standard Care

NO INTERVENTION

Participants will receive one exercise counseling session as part of their baseline assessment. Participants in the control group will not undergo any other exercise counseling or formal exercise intervention, but will not be prohibited from participating in exercise outside of the study protocol.

Interventions

Exercise Rehabilitation BEHAVIORAL

This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks

Exercise Rehabilitation

Eligibility Criteria

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

You may qualify if:

• greater than 3 months after starting chronic hemodialysis
• no planned change in hemodialysis modality or relocation outside of Winnipeg during study intervention period (26 weeks)
• assessed to be safe and able to exercise by HD unit nephrologist
• ability to communicate in English and provide informed written consent

You may not qualify if:

• acute coronary syndrome in past 3 months
• unstable arrhythmia
• shortness of breath at rest or with minimal activity (NYHA Class 4)
• symptomatic hypoglycaemia (\> 2x/week in week prior to enrolment)
• currently participating in the Manitoba Renal Program clinical intradialytic cycling program
• score of 0 on Dialysis Symptom Index when administered at time of consent

Sponsors & Collaborators

• University of Manitoba: lead
• The Wellness Institute at Seven Oaks General Hospital: collaborator

Study Sites (3)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Related Links

• Study Protocol Publication

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Clara J Bohm, MD, MPH

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: May 1, 2015
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)