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Exercise in Patients With End Stage Kidney Disease

ConditionRenal Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Prescription

    Behavioral

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Exercise InterventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment Feasibility

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.

Time frame
30 months
2

Adherence

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.

Time frame
12 months

Secondary outcomes

1

Hand Grip Strength

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)

Time frame
12 months
2

Quality of Life using Vitality Subscale

Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)

Time frame
12 months
3

Sleep Quality

Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).

Time frame
12 months
4

Hospitalizations

The number of hospitalizations per patient year

Time frame
12 months

Other outcomes

Sponsors and contacts

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Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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