Chronic Heart FailureNCT02223624
Effect of an Eccentric Exercise Program on Quality of Life and Function in People With Chronic Heart Failure.
A study testing walking and light weights, eccentric aerobic exercise and concentric aerobic exercise in people with Chronic Heart Failure, run by La Trobe University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- walking and light weights, eccentric aerobic exercise and concentric aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2014to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
BACKGROUND A systematic literature review we conducted yielded two trials investigating eccentric exercise in patients with coronary artery disease and two trials in the chronic heart failure population. Eccentric exercise was reported to be a safe form of exercise for coronary patients, causing minimal heart and breathing stress and being perceived as "fairly light" exertion. Eccentric exercise, when compared with concentric exercise (shortening contractions) resulted in comparable improvements in muscle strength and walking distance, often with reduced oxygen usage.
With no increase in negative events with coronary patients, recently eccentric exercise has been trialed in heart failure patients. One trial looked at six-minute walk test differences in patients with mild heart failure following a program of eccentric or concentric cycling. They found that although both groups improved their walking distance, the eccentric exercise was completed at lower levels of work and stable heart rates. A second trial completed eccentric exercise by descending stairs, compared with participants who climbed stairs and measured knee muscle strength. They reported that participants found the stair descending easy with significant improvements in static strength but not eccentric (lengthening) or concentric (shortening) force. Both of these studies were limited by a population of a small number (12-15) of participants primarily males, with poorly defined or mild heart failure.
RESEARCH AIMS Given the limited evidence in coronary patients and more specifically heart failure patients, this current study aims to fill knowledge gaps by looking at the effects of eccentric exercise on both males and females, with mild to moderate heart failure, of both heart failure types- systolic (heart contraction problems) and diastolic (heart relaxation problems). We aim to include measures of both function and quality of life. We will also monitor compliance and patient satisfaction with the aim of developing a safe and tolerable exercise program that is feasible for implementation in heart failure rehabilitation programs.
METHODS Participants will be recruited through The Northern Hospital heart failure outpatient medical clinics and also through referral to the current rehabilitation program following inpatient admission or G.P referral. This study will be a prospective, three-armed, parallel-design, randomised controlled trial with a 1:1:1 ratio. A separate randomisation procedure will be prepared for each of the three included New York heart association heart failure classes so that disease severity will not affect the results.
As well as the primary outcomes of walking capacity and quality of life, secondary outcomes will include lower limb strength and levels of fatigue. We will also monitor adherence, attendance, pain, and any adverse events occurring in any session.
Demographic and outcome data will be analysed for between group differences at baseline. To determine whether group 1 improved more than groups 2 and 3 immediately after the 8-week program, data will be analysed with analysis of covariance using the baseline measures as covariates. Categorical outcome variables (death or hospital admission) will be analysed with relative risk ratios. To avoid bias and to maximise the randomisation process, intention to treat analysis will be utilised. Participants withdrawing from the project will be followed up where possible. Where data are missing, the carry forward technique will be used, which assumes that missing data remain constant. Finally, correlations between the secondary outcome variables and the primary outcome variables will also be examined to detect where associations exist as well as associations between outcomes and types of heart failure (systolic or diastolic). Significance level of P<.05 will be used for hypotheses testing.
- Conditions
- Chronic Heart Failure
- Being tested
- walking and light weights, eccentric aerobic exercise, concentric aerobic exercise
- Keywords
- eccentric, exercise, heart disease, chronic heart failure, rehabilitation
- Medical subject headings
- Motor Activity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking and light weightsOther
eccentric aerobic exerciseOther
concentric aerobic exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| eccentric aerobic exercise group | Experimental | Eccentric 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. Receives: Other: walking and light weights; Other: eccentric aerobic exercise |
| Concentric aerobic exercise group | Active comparator | Concentric 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. Receives: Other: walking and light weights; Other: concentric aerobic exercise |
| Waiting list control | No intervention | Waiting 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional improvement measured by change in six-minute walk distance
Measured: post 8-week exercise program and 3-month follow-up
Secondary outcomes (1)
Quality of life measured by participant questionnaire
Measured: post 8-week exercise program and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Trobe University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Hospital, Australia
- Responsible party
- Principal investigator, Rachel Ellis, La Trobe University
- Investigators
- Rachel E Ellis, Principal investigator, Northern Hospital, AustraliaKwang Lim, Principal investigator, Melbourne HealthKaren J Dodd, Principal investigator, Victoria UniversityAnne E Holland, Principal investigator, La Trobe UniversityNora Shields, Principal investigator, La Trobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223624
- Sponsor's protocol ID
- LR49.2013 FHEC13/260 LaTrobeU
- Other IDs
- LR 49.2013
- Status last verified
- Feb 2020
- First submitted
- 21 Aug 2014
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33174464
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02223624
- Acronym / sponsor ID
- LR49.2013 FHEC13/260 LaTrobeU
- Conditions
- Chronic Heart Failure
- Keywords
- eccentric, exercise, heart disease, chronic heart failure, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- La Trobe UniversityUniversity, hospital or other
- Collaborators
- Northern Hospital, Australia
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND A systematic literature review we conducted yielded two trials investigating eccentric exercise in patients with coronary artery disease and two trials in the chronic heart failure population. Eccentric exercise was reported to be a safe form of exercise for coronary patients, causing minimal heart and breathing stress and being perceived as "fairly light" exertion. Eccentric exercise, when compared with concentric exercise (shortening contractions) resulted in comparable improvements in muscle strength and walking distance, often with reduced oxygen usage.
With no increase in negative events with coronary patients, recently eccentric exercise has been trialed in heart failure patients. One trial looked at six-minute walk test differences in patients with mild heart failure following a program of eccentric or concentric cycling. They found that although both groups improved their walking distance, the eccentric exercise was completed at lower levels of work and stable heart rates. A second trial completed eccentric exercise by descending stairs, compared with participants who climbed stairs and measured knee muscle strength. They reported that participants found the stair descending easy with significant improvements in static strength but not eccentric (lengthening) or concentric (shortening) force. Both of these studies were limited by a population of a small number (12-15) of participants primarily males, with poorly defined or mild heart failure.
RESEARCH AIMS Given the limited evidence in coronary patients and more specifically heart failure patients, this current study aims to fill knowledge gaps by looking at the effects of eccentric exercise on both males and females, with mild to moderate heart failure, of both heart failure types- systolic (heart contraction problems) and diastolic (heart relaxation problems). We aim to include measures of both function and quality of life. We will also monitor compliance and patient satisfaction with the aim of developing a safe and tolerable exercise program that is feasible for implementation in heart failure rehabilitation programs.
METHODS Participants will be recruited through The Northern Hospital heart failure outpatient medical clinics and also through referral to the current rehabilitation program following inpatient admission or G.P referral. This study will be a prospective, three-armed, parallel-design, randomised controlled trial with a 1:1:1 ratio. A separate randomisation procedure will be prepared for each of the three included New York heart association heart failure classes so that disease severity will not affect the results.
As well as the primary outcomes of walking capacity and quality of life, secondary outcomes will include lower limb strength and levels of fatigue. We will also monitor adherence, attendance, pain, and any adverse events occurring in any session.
Demographic and outcome data will be analysed for between group differences at baseline. To determine whether group 1 improved more than groups 2 and 3 immediately after the 8-week program, data will be analysed with analysis of covariance using the baseline measures as covariates. Categorical outcome variables (death or hospital admission) will be analysed with relative risk ratios. To avoid bias and to maximise the randomisation process, intention to treat analysis will be utilised. Participants withdrawing from the project will be followed up where possible. Where data are missing, the carry forward technique will be used, which assumes that missing data remain constant. Finally, correlations between the secondary outcome variables and the primary outcome variables will also be examined to detect where associations exist as well as associations between outcomes and types of heart failure (systolic or diastolic). Significance level of P<.05 will be used for hypotheses testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eccentric aerobic exercise group | Experimental | Other: walking and light weights, Other: eccentric aerobic exerciseEccentric 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 comparator | Other: walking and light weights, Other: concentric aerobic exerciseConcentric 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 intervention | –Waiting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking and light weights | Other | Concentric aerobic exercise group, eccentric aerobic exercise group |
| eccentric aerobic exercise | Other | eccentric aerobic exercise group |
| concentric aerobic exercise | Other | Concentric aerobic exercise group |
Primary outcome
functional improvement measured by change in six-minute walk distance
Time frame: post 8-week exercise program and 3-month follow-up
1 secondary outcome
Quality of life measured by participant questionnaire
Time frame: post 8-week exercise program and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 33174464Ellis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel E Ellis principal investigator
Northern Hospital, Australia
Kwang Lim principal investigator
Melbourne Health
Karen J Dodd principal investigator
Victoria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking and light weights, eccentric aerobic exercise and concentric aerobic exercise in people with Chronic Heart Failure, run by La Trobe University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional improvement measured by change in six-minute walk distance (time frame: post 8-week exercise program and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.