Exercise in Patients With End Stage Kidney Disease

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT03787589

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.

The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Behavioral: Exercise Prescription	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study

Actual Study Start Date :

Apr 15, 2019

Anticipated Primary Completion Date :

Jul 15, 2022

Anticipated Study Completion Date :

Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Intervention Participants in this arm will receive standard of care along with the exercise prescription intervention	Behavioral: Exercise Prescription Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps. All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.
No Intervention: Standard of Care This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

Arm

Intervention/Treatment

Experimental: Exercise Intervention

Participants in this arm will receive standard of care along with the exercise prescription intervention

Behavioral: Exercise Prescription

Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps. All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.

No Intervention: Standard of Care

This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

Outcome Measures

Primary Outcome Measures

Recruitment Feasibility [30 months]
The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
Adherence [12 months]
Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.

Secondary Outcome Measures

Hand Grip Strength [12 months]
The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)
Quality of Life using Vitality Subscale [12 months]
Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
Sleep Quality [12 months]
Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Hospitalizations [12 months]
The number of hospitalizations per patient year
Hospital Length of Stay [12 months]
Average number of days spent in hospital
Change in Living Status [12 months]
Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Safety of the Exercise Program [12 months]
Safety will be measured by monitoring serious adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All ambulatory adult patients with end stage kidney disease
Treatment with peritoneal dialysis or hemodialysis for greater than six months
Able to understand English or French
Abuse to use Nordic Walking poles
Able and willing to provide informed consent

Exclusion Criteria:

Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
Baseline step count greater than 8000 steps a day
Planned living donor kidney transplant
Potential for recovery of renal function
Patients who feel unsafe using Nordic walking poles in place of their mobility aid
Participation in another interventional trial that may affect the results of this study