Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02223624




Registration number
NCT02223624
Ethics application status
Date submitted
21/08/2014
Date registered
22/08/2014
Date last updated
20/02/2020

Titles & IDs
Public title
Effect of an Eccentric Exercise Program on Quality of Life and Function in People With Chronic Heart Failure.
Scientific 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.
Secondary ID [1] 0 0
LR 49.2013
Secondary ID [2] 0 0
LR49.2013 FHEC13/260 LaTrobeU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: eccentric aerobic exercise group - 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.

Active comparator: Concentric aerobic exercise group - 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.

No intervention: Waiting list control - 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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
functional improvement measured by change in six-minute walk distance
Timepoint [1] 0 0
post 8-week exercise program and 3-month follow-up
Secondary outcome [1] 0 0
Quality of life measured by participant questionnaire
Timepoint [1] 0 0
post 8-week exercise program and 3-month follow-up

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2019
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
3076 - Epping

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Hospital, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel E Ellis
Address 0 0
Northern Hospital, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02223624