- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061319
Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in Exercise Capacity Measured by 6 Minute Walk Test
Time Frame: Baseline and 12 weeks.
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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
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Baseline and 12 weeks.
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Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Physical Activity
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Left Ventricular Filling Pressures
Time Frame: Baseline and 12 weeks
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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
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Cardiopulmonary Fitness by VO2 Peak
Time Frame: Baseline and 12 weeks
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assessed using CPET
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Baseline and 12 weeks
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Body Mass Index
Time Frame: Baseline and 12 weeks
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Baseline and 12 weeks
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Calf Circumference
Time Frame: Baseline and 12 weeks
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Baseline and 12 weeks
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Waist Circumference
Time Frame: Baseline and 12 weeks
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Baseline and 12 weeks
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Blood Levels of N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Time Frame: Baseline and 12 weeks
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Baseline and 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Robert Reid, Dr., Ottawa Heart Institute Research Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20130774-01H
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