Effect of an Eccentric Exercise Program on Quality of Life and Function in People With Chronic Heart Failure.
Effect of an Eccentrically Biased Aerobic Exercise Program on Quality of Life and Functional Capacity in People With Chronic Heart Failure: A Randomized Controlled Trial.
2 other identifiers
interventional
47
1 country
1
Brief Summary
Many studies have shown that exercise training is beneficial for patients with chronic heart failure (CHF). Heart Foundation guidelines strongly recommend regular physical activity and referral to a specifically designed rehabilitation program for all patients with CHF who are medically stable. Such programs usually comprise aerobic exercises such as walking, and light weightlifting with care to avoid heavy straining due to stress that this may place on the heart. Eccentric contractions are those in which the muscle lengthens as it contracts. Exercise involving eccentric contractions is known to increase muscle strength and this type of exercise also requires less oxygen. This is because it requires less power to resist lowering a weight than it does to lift a weight. Initial evidence suggests that this form of exercise has favourable outcomes in the frail elderly and those with chronic disease. This study aims to determine if eccentric exercise can be applied to patients with heart failure to increase their physical function while using less energy so that exercise is more tolerable for patients who complain of significant breathlessness and fatigue. This study also aims to determine if eccentric exercise is a safe alternative exercise option for patients at risk of negative events. The investigators propose to run a randomised controlled trial. Eccentric exercise will be delivered to a group of heart failure patients referred to the existing heart failure rehabilitation program at the Northern Hospital. The program will consist of eight weeks of twice weekly exercise of one hour's duration comprising eccentric exercise combined with walking and light weight training. This will be compared to a group of patients participating in the current exercise program consisting of light weightlifting and aerobic exercises for the same length and duration of exercise and also to a third group of patients who will be wait listed for 8 weeks. Following the completion of the eight week waiting period, these patients will be offered the option of joining the standard exercise program. The investigators expect that the eccentric exercise group will have improved walking capacity and quality of life compared with the traditional program and the wait-list control group. It is also possible that there is no difference between the eccentric and traditional program in terms of functional outcomes but that the participants report that eccentric exercise is easier.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFebruary 20, 2020
February 1, 2020
4.6 years
August 21, 2014
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional improvement measured by change in six-minute walk distance
post 8-week exercise program and 3-month follow-up
Secondary Outcomes (1)
Quality of life measured by participant questionnaire
post 8-week exercise program and 3-month follow-up
Other Outcomes (2)
Fatigue as measured by participant questionnaire
post 8-week exercise program and 3-month follow-up
lower limb strength as measured as a one-repetition maximum leg press
post 8-week exercise program and 3-month follow-up
Study Arms (3)
eccentric aerobic exercise group
EXPERIMENTALEccentric aerobic exercise group: Participants in this group will participate in an eccentric aerobic exercise rehabilitation program for a total of eight weeks, two sessions per week. Outcome measurements will be taken post exercise program and also after a 3 month follow-up period. Each session will be approximately 60 minutes in duration and include approximately 10 minutes of warm up (stretches), eccentric stepper aiming for 20 minutes, walking and light weights, followed by a five minute cool-down period.
Concentric aerobic exercise group
ACTIVE COMPARATORConcentric aerobic exercise group (usual care): The length of the concentric aerobic exercise based rehabilitation program will be the same as the study group- twice weekly exercise sessions for 8 weeks. Outcome measurements will also be taken after a 3-month follow-up period. Participants in the concentric aerobic exercise group will participate in the same warm-up and cool down period as the eccentric group. They will also complete walking and light weights. To replace the 20 minutes of eccentric exercise, concentric participants will complete approximately 20 minutes of exercise bike, stair climbing and rowing as able with required rests.
Waiting list control
NO INTERVENTIONWaiting list (no exercise): Participants assigned to this group will not receive any intervention during the study period. They will be assessed like other participants at baseline and after eight weeks, but not at three-month follow-up due to ethical concerns around withholding care known to be effective. Given that there is a waiting list for the current exercise program of 4-12 weeks, it is felt that delaying care for a set period of eight weeks is not of ethical concern. Following the completion of assessments, waiting list participants will be able to complete the traditional exercise program as usual but not as participants of the study's experimental groups.
Interventions
Eligibility Criteria
You may qualify if:
- aged \> 18 years
- a clinical diagnosis of heart failure either systolic or diastolic on transthoracic echocardiogram
- mild to moderate heart failure
- medically stable heart failure
- have received approval when assessed by the group physiotherapist to participate in the exercise program as is usual practice. Where concerns arise during assessment, clearance will be sought from the treating cardiologist.
You may not qualify if:
- hospitalisation for a CHF exacerbation within the previous month
- severe heart failure classified as level four on the New York heart association classification (short of breath at rest)
- unstable medical condition such as uncontrolled angina, diabetes or hypertension
- dementia or a psychological disorder that would interfere with participation in group exercise
- participation in a cardiac or heart failure rehabilitation program in the prior six months
- contraindications to exercise (ie aneurysm, valvular disease)
- the presence of any pre-existing neurological or musculoskeletal condition, for example stroke, that on assessment is deemed to interfere with exercise participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- La Trobe Universitylead
- Northern Hospital, Australiacollaborator
Study Sites (1)
The Northern Hospital
Epping, Victoria, 3076, Australia
Related Publications (1)
Ellis RE, Dodd KJ, Holland AE, Lim K, Tacey M, Shields N. Effect of eccentric exercise on quality of life and function in people with chronic heart failure: a pilot randomised controlled trial. Disabil Rehabil. 2022 Jun;44(12):2705-2714. doi: 10.1080/09638288.2020.1836679. Epub 2020 Nov 11.
PMID: 33174464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel E Ellis
Northern Hospital, Australia
- PRINCIPAL INVESTIGATOR
Kwang Lim
Melbourne Health
- PRINCIPAL INVESTIGATOR
Karen J Dodd
Victoria University
- PRINCIPAL INVESTIGATOR
Anne E Holland
La Trobe University
- PRINCIPAL INVESTIGATOR
Nora Shields
La Trobe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Leader Physiotherapist
Study Record Dates
First Submitted
August 21, 2014
First Posted
August 22, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
February 20, 2020
Record last verified: 2020-02