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

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT02061319
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Study Start: 2014-03
• Primary Completion: 2016-12-31
• Study Completion: 2017-08-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in exercise capacity measured by 6 minute walk test	Baseline, 12 weeks, 26 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

Secondary Outcome Measures

Name	Time	Method
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)	Baseline, 12 weeks, 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.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada