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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nordic Walking Group
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
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
No Intervention: Standard Exercise Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Exercise Capacity Measured by 6 Minute Walk Test
Time Frame: Baseline and 12 weeks.
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
Baseline and 12 weeks.
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time Frame: Baseline and 12 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. Each item is scored 0-5, and the total scores is the summed score of all items, totaling 0 - 105. Higher scores represent lower quality of life.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Live Using the Medical Outcomes Study Short Form (SF-36)
Time Frame: Baseline and 12 weeks
Total scale is split into 2 subscales: physical component summary (PCS) and mental composition summary (MCS). Each subscale ranges from 0-100. Higher scores represent better quality of life.
Baseline and 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and 12 weeks
Split into 2 subscales: anxiety and depression. Each subscale has 7 items, scored from 0-3, with the total score of each subscale being 0-21 each. Higher scores indicate greater anxiety or depression. 0-7 indicates a normal range.
Baseline and 12 weeks
Physical Activity
Time Frame: Baseline and 12 weeks
Physical activity includes any type of exercise. For example, walking, swimming, biking etc. Identification of "light", "moderate" or "vigourous" activity is determined by the participant based on perceived effort. Results are collected from exercise journals.
Baseline and 12 weeks
Left Ventricular Filling Pressures
Time Frame: Baseline and 12 weeks

The left ventricular filling pressure is the pressure inside the left ventricle of the heart during the resting phase of the heart beat when the chamber fills with blood. It is assessed by echocardiography and calculate as an E/e' ratio, where E = the peak velocity of early diastolic blood flow across the mitral valve, and e' = the peak velocity of mitral valve annulus during early diastole, which is a measure of how fast the heart muscle relaxes.

Valus <8 are considered normal, 8-14 indicates potentially normal, but is baseline and requires further evaluation and >/= 15 suggests elevated pressures and presence of diastolic dysfunction or heart failure with preserved ejection fraction.

Baseline and 12 weeks
Cardiopulmonary Fitness by VO2 Peak
Time Frame: Baseline and 12 weeks
assessed using CPET
Baseline and 12 weeks
Body Mass Index
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Calf Circumference
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Waist Circumference
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Blood Levels of N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Reid, Dr., Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimated)

February 12, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

February 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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