Heart Failure
Conditions
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
Interventions
BEHAVIORALNordic Walking
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
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Exercise Capacity Measured by 6 Minute Walk Test | 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 |
| Minnesota Living With Heart Failure Questionnaire (MLHFQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Live Using the Medical Outcomes Study Short Form (SF-36) | 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. |
| Hospital Anxiety and Depression Scale (HADS) | 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. |
| Physical Activity | 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. |
| Left Ventricular Filling Pressures | 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. |
| Cardiopulmonary Fitness by VO2 Peak | Baseline and 12 weeks | assessed using CPET |
| Body Mass Index | Baseline and 12 weeks | — |
| Calf Circumference | Baseline and 12 weeks | — |
| Waist Circumference | Baseline and 12 weeks | — |
| Blood Levels of N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | Baseline and 12 weeks | — |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRobert Reid, Dr.
Ottawa Heart Institute Research Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 3 / 26 | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
None listed