Clinical trial NCT02061319: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Changes in exercise capacity measured by 6 minute walk test
timeFrame: Baseline, 12 weeks, 26 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 12 weeks, 26 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Reid, Dr.
role: PRINCIPAL_INVESTIGATOR
References: