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Exercise in Patients With End Stage Kidney Disease

Primary Purpose

Renal Failure

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Prescription
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Renal Failure, Hemodialysis, Peritoneal Dialysis, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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]
  2. Baseline step count greater than 8000 steps a day
  3. Planned living donor kidney transplant
  4. Potential for recovery of renal function
  5. Patients who feel unsafe using Nordic walking poles in place of their mobility aid
  6. Participation in another interventional trial that may affect the results of this study

Sites / Locations

  • Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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)
Sleep Quality
Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Hospitalizations
The number of hospitalizations per patient year
Hospital Length of Stay
Average number of days spent in hospital
Change in Living Status
Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Safety of the Exercise Program
Safety will be measured by monitoring serious adverse events

Full Information

First Posted
October 1, 2018
Last Updated
September 29, 2022
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03787589
Brief Title
Exercise in Patients With End Stage Kidney Disease
Official Title
A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Renal Failure, Hemodialysis, Peritoneal Dialysis, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive standard of care along with the exercise prescription intervention
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
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
Title
Adherence
Description
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 Outcome Measure Information:
Title
Hand Grip Strength
Description
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
Title
Quality of Life using Vitality Subscale
Description
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
Title
Sleep Quality
Description
Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Time Frame
12 months
Title
Hospitalizations
Description
The number of hospitalizations per patient year
Time Frame
12 months
Title
Hospital Length of Stay
Description
Average number of days spent in hospital
Time Frame
12 months
Title
Change in Living Status
Description
Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Time Frame
12 months
Title
Safety of the Exercise Program
Description
Safety will be measured by monitoring serious adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Zimmerman, MD, MSc
Phone
613-738-8400
Ext
82534
Email
dzimmerman@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Zimmerman, MD, MSc
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Zimmerman, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
IPD Sharing Time Frame
One year after publication up to 3 years post publication
IPD Sharing Access Criteria
researchers with methodologically sound proposals approved by the principal investigator

Learn more about this trial

Exercise in Patients With End Stage Kidney Disease

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