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Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nordic Walking
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has a confirmed diagnosis of HF based on a HF admission and/or a clear diagnosis of HF and/or reduced ejection fraction (≤45% measured by echocardiography within the last six months);
  • Patient is referred to cardiac rehabilitation program;
  • Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
  • In the opinion of the referring physician, the patient is medically stable, and able to participate in an exercise program
  • Patient is able, in the opinion of the qualified investigator, to comprehend and participate in the exercise intervention;
  • Patient is 18 years of age or older;
  • Patient is willing to provide informed consent.

Exclusion Criteria:

  • Patient is unable to read and understand English or French
  • Patient intends to begin cardiac rehabilitation within the next 6 weeks
  • Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks;
  • Patient is currently using Nordic Walking poles.

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nordic Walking Group

Standard Exercise Therapy

Arm Description

Participants in the Nordic walking group will be provided with walking poles (GymstickTM Nordic Walking Poles, Gymstick International OY, Lahti, Finland) for the duration of the study. They will attend on-site exercise classes twice weekly for 12 weeks. The on-site exercise training classes will be one hour in length and include the following components: a 15 minute chair warm-up that excludes resistance exercises; 10-15 minutes of walking with Nordic walking poles for the first 3 weeks, progressing to 30 minutes of continuous walking with poles for the remaining 9 weeks; and 15 minutes of cool down exercises. Participants will be instructed to take the walking poles home and perform 200-400 minutes of Nordic walking per week for 12 weeks

Individuals assigned to standard exercise therapy will attend on-site exercise classes twice weekly for 12 weeks. Each on-site class will be one hour in duration and consist of: a 15-minute chair-based warm-up that includes 6-8 upper and lower body resistance training exercises using either hand-held weights or therabands at an intensity of 50-60% of 1- RM with the patient completing one set of 10-12 repetitions progressing to 15 repetitions before increasing the intensity by 5-10%; 10-15 minutes of walking for the first 3 weeks, progressing to 30 minutes of continuous walking for the remaining 9 weeks; and 15 minutes of cool down exercises. A strength training program will be provided to participants and they will be encouraged to do one additional strength training session at home. Participants will also be instructed to complete additional walking sessions at home so that they can accumulate a total of 200-400 minutes of exercise per week.

Outcomes

Primary Outcome Measures

Changes in exercise capacity measured by 6 minute walk test
The 6 minute walk test was selected as a primary outcome because this sub-maximal test is a good indicator of the capacity to undertake day-to-day activities in patients with Heart Failure

Secondary Outcome Measures

Changes in disease-specific health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire, over the 12-week intervention period and after a 14-week unsupervised observation period (at 26 weeks)
The MLHFQ is a 21-item scale that measures the effects of HF-related symptoms, functional limitations, and psychological distress on an individual's quality of life. Participants are asked to indicate using a 6-point, zero to five, Likert scale how much each of 21 factors prevent them from living as they desire. The total score is the best measure of how HF and treatments impact an individual's quality of life.

Full Information

First Posted
February 10, 2014
Last Updated
February 24, 2022
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02061319
Brief Title
Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure
Official Title
Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of our project is to see if a 12-week program of Nordic walking is better than standard exercise therapy for increasing exercise capacity (measured by how far people can walk in 6 minutes) and increasing quality of life (measured by having people fill out two questionnaires). We will also see if Nordic walking: improves heart performance (measured by heart ultrasound); improves how active people are (measured by an activity monitor); increases aerobic fitness (measured by a treadmill test); improves body composition (measured by waist size); and reduces hormone levels in the blood.
Detailed Description
A single-site, parallel-group, randomized controlled trial will be conducted (Appendix C) at the University of Ottawa Heart Institute (UOHI). Patients with stable HF referred to cardiac rehabilitation will undergo baseline assessment and then be randomly assigned (1:1) to either standard exercise therapy (consisting of regular walking and a resistance exercise program) or Nordic walking. Follow-up measures will be taken at the end of intervention (12 weeks) and after a 14-week no-intervention observation period (26 weeks). After initial randomization to treatment group, participants will be stratified by treatment group and randomly assigned to one of three follow-up measurement conditions at 12 weeks: echocardiograph and cardiopulmonary test (N=80); cardiopulmonary test only (N=60); or no follow-up echocardiograph or cardiopulmonary test (N=76). The primary outcomes will be: a) changes in exercise capacity measured by 6MWT; and b) changes in disease-specific HRQL measured by the MLHFQ. Additional measures will examine the effects of the exercise interventions on: cardiac performance; leisure time activity; cardio-respiratory fitness; body composition; neurohormonal activation; and generic HRQL

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nordic Walking Group
Arm Type
Experimental
Arm Description
Participants in the Nordic walking group will be provided with walking poles (GymstickTM Nordic Walking Poles, Gymstick International OY, Lahti, Finland) for the duration of the study. They will attend on-site exercise classes twice weekly for 12 weeks. The on-site exercise training classes will be one hour in length and include the following components: a 15 minute chair warm-up that excludes resistance exercises; 10-15 minutes of walking with Nordic walking poles for the first 3 weeks, progressing to 30 minutes of continuous walking with poles for the remaining 9 weeks; and 15 minutes of cool down exercises. Participants will be instructed to take the walking poles home and perform 200-400 minutes of Nordic walking per week for 12 weeks
Arm Title
Standard Exercise Therapy
Arm Type
No Intervention
Arm Description
Individuals assigned to standard exercise therapy will attend on-site exercise classes twice weekly for 12 weeks. Each on-site class will be one hour in duration and consist of: a 15-minute chair-based warm-up that includes 6-8 upper and lower body resistance training exercises using either hand-held weights or therabands at an intensity of 50-60% of 1- RM with the patient completing one set of 10-12 repetitions progressing to 15 repetitions before increasing the intensity by 5-10%; 10-15 minutes of walking for the first 3 weeks, progressing to 30 minutes of continuous walking for the remaining 9 weeks; and 15 minutes of cool down exercises. A strength training program will be provided to participants and they will be encouraged to do one additional strength training session at home. Participants will also be instructed to complete additional walking sessions at home so that they can accumulate a total of 200-400 minutes of exercise per week.
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking
Intervention Description
Participants in the Nordic walking group will be provided with walking poles (GymstickTM Nordic Walking Poles, Gymstick International OY, Lahti, Finland) for the duration of the study. They will attend on-site exercise classes twice weekly for 12 weeks. The on-site exercise training classes will be one hour in length and include the following components: a 15 minute chair warm-up that excludes resistance exercises; 10-15 minutes of walking with Nordic walking poles for the first 3 weeks, progressing to 30 minutes of continuous walking with poles for the remaining 9 weeks; and 15 minutes of cool down exercises. Participants will be instructed to take the walking poles home and perform 200-400 minutes of Nordic walking per week for 12 weeks
Primary Outcome Measure Information:
Title
Changes in exercise capacity measured by 6 minute walk test
Description
The 6 minute walk test was selected as a primary outcome because this sub-maximal test is a good indicator of the capacity to undertake day-to-day activities in patients with Heart Failure
Time Frame
Baseline, 12 weeks, 26 weeks
Secondary Outcome Measure Information:
Title
Changes in disease-specific health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire, over the 12-week intervention period and after a 14-week unsupervised observation period (at 26 weeks)
Description
The MLHFQ is a 21-item scale that measures the effects of HF-related symptoms, functional limitations, and psychological distress on an individual's quality of life. Participants are asked to indicate using a 6-point, zero to five, Likert scale how much each of 21 factors prevent them from living as they desire. The total score is the best measure of how HF and treatments impact an individual's quality of life.
Time Frame
Baseline, 12 weeks, 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has a confirmed diagnosis of HF based on a HF admission and/or a clear diagnosis of HF and/or reduced ejection fraction (≤45% measured by echocardiography within the last six months); Patient is referred to cardiac rehabilitation program; Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks; In the opinion of the referring physician, the patient is medically stable, and able to participate in an exercise program Patient is able, in the opinion of the qualified investigator, to comprehend and participate in the exercise intervention; Patient is 18 years of age or older; Patient is willing to provide informed consent. Exclusion Criteria: Patient is unable to read and understand English or French Patient intends to begin cardiac rehabilitation within the next 6 weeks Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks; Patient is currently using Nordic Walking poles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Reid, Dr.
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure

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