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

NCT02061319 | Completed

• 1 other identifier: 20130774-01H
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 12 weeks, 26 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Nordic Walking Group

EXPERIMENTAL

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

Behavioral: Nordic Walking

Standard Exercise Therapy

NO INTERVENTION

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.

Interventions

Nordic Walking BEHAVIORAL

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

Nordic Walking Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Robert Reid, Dr.

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: March 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: August 31, 2017
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

CA (1)