Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

End-stage Renal Disease Clinical Trial

Official title:

Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259413
• Other study ID #: B2014:088
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 8, 2023

Study information

• Verified date: June 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which have limited effective treatments. Symptom burden, the combined impact of number and severity of symptoms, negatively impacts functional status and health-related quality of life (HRQOL) in HD. Small interventional trials suggest exercise can mitigate specific individual symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis patients have identified improving symptom burden and HRQOL as research priorities. We propose the first randomized controlled trial (RCT) investigating the effect of exercise rehabilitation on symptom burden in individuals on HD.

Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab) program will reduce symptom burden and improve HRQOL, resulting in reduced disability and improved long-term clinical outcomes as compared with standard care.

Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and assessor blinding

Study Population: Adults receiving chronic in-centre HD for > 3 months with at least one dialysis-related symptom; n=150

Intervention: Standard care plus 26-week structured rehab program (lifestyle education, resistance exercise and cycling during HD).

Control: Standard care (baseline exercise counseling)

Outcomes measured at baseline, 12, 26 and 52 weeks.

Data Analysis: Will be performed on an intention to treat, available case basis with t-tests or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for categorical outcomes. Mixed effects modeling will account for repeated outcome measures over time. Poisson regression will be performed for hospitalization analysis.

Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline in the intervention group at 12 weeks. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 months. In contrast, the control group will see no improvement in symptom burden from baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

Behavioral:
• Exercise Rehabilitation
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

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	Seven Oaks General Hospital	Winnipeg	Manitoba
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	The Wellness Institute at Seven Oaks General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity behaviour pattern	Measured in 2 ways: Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire; Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point; 2.	Measured at study baseline, 12, 26 and 52 weeks after study start
Other	Hospitalization rate	Measured by number of hospitalizations and length of stay for each hospitalization	Measured at study baseline, 12, 26 and 52 weeks after study start
Other	Mortality	Measured as the proportion of people who died during the first year on dialysis	Measured at 1 year after starting dialysis
Primary	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	Change in dialysis symptom burden at 26 and 52 weeks	Measured using change in the Dialysis Symptom Index	Measured at study baseline, 26 and 52 weeks after study start
Secondary	Change in modified symptom burden	Measured using change in modified Dialysis Symptom Index	Measured at study baseline, 12, 26 and 52 weeks after study start
Secondary	Change in health-related quality of life	Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.	Measured at study baseline, 12, 26 and 52 weeks after study start
Secondary	Change in time for recovery post-dialysis	Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"	Measured at study baseline, 12, 26 and 52 weeks after study start
Secondary	Change in endurance/exercise capacity	Measured using the Incremental Shuttle Walk Test	Measured at study baseline, 12, 26 and 52 weeks after study start
Secondary	Change in frailty status	Measured using the Modified Fried Criteria for frailty.	Measured at study baseline, 12, 26 and 52 weeks after study start
Secondary	Change in self-efficacy for exercise	Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool	Measured at study baseline, 12, 26 and 52 weeks after study start