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Trial registered on ANZCTR


Registration number
ACTRN12611000036910
Ethics application status
Approved
Date submitted
7/01/2011
Date registered
11/01/2011
Date last updated
28/09/2021
Date data sharing statement initially provided
28/09/2021
Date results information initially provided
28/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Aquatic versus land based exercise training : impact on functional outcomes in patients with stable heart failure
Scientific title
Aquatic versus land based exercise training : impact on functional outcomes in patients with stable heart failure
Secondary ID [1] 253117 0
no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 260922 0
Condition category
Condition code
Cardiovascular 258825 258825 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 259078 259078 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated into Group A (6-weeks aquatic exercise) or Group B (6-weeks land exercise) first. Participants will undertake both exercise blocks with a washout period of 1 week in between. Both the aquatic and land – based exercise interventions will involve one session per week, lasting 60 minutes, for 6 weeks.
Exercise sessions for both the land and water based interventions will be conducted as per current evidence for exercise and chronic heart failure and the land programme will reflect that currently conducted at each trial site. As such, both programmes will include a warm up and cool down period of 10 minutes duration, as well as a combination of upper limb and lower limb aerobic and resistance activities. Each session will also include 10 minutes of balance activities. Exercise intensity will be similar in both the land and water based programmes (9-13 on the Borg scale), ensuring that the only difference between the 2 groups is the type of exercise performed (ie water versus land).
Intervention code [1] 257638 0
Rehabilitation
Intervention code [2] 257818 0
Treatment: Other
Comparator / control treatment
Water versus land exercise
Control group
Active

Outcomes
Primary outcome [1] 259934 0
Six minute walk test - change in walking distance
Timepoint [1] 259934 0
baseline, 6 weeks, 13 weeks
Secondary outcome [1] 268840 0
Balance outcome- using the Balance Outcome Measure for Elder Rehabilitation (BOOMER)

The BOOMER is a global measure of standing balance incorporating 4 commonly used balance tests including: the Timed Up and Go test (TUG), functional reach test (FRT), step test and the static standing with eyes closed test. Results from tests are combined to provide a single score for each individual.
Timepoint [1] 268840 0
baseline, 6 weeks, 13 weeks
Secondary outcome [2] 268841 0
Quality of Life - using the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
Timepoint [2] 268841 0
baseline, 6 weeks, 13 weeks
Secondary outcome [3] 401438 0
Grip strength: Grip strength will be measured using a handheld Saehan dynamometer. Three measures will be performed on each arm and the best result recorded.
Timepoint [3] 401438 0
Grip strength will be measured at baseline, week 7 following the initial training intervention and week 14 following the second training intervention.
Secondary outcome [4] 401439 0
10 metre walk speed: Walk speed will be measured on a 14 metre flat track. To account for acceleration and deceleration effects, the time taken for the participant to walk only the middle ten metres of the track was recorded. Participants were asked to undertake the test at both a comfortable “like a walk in the park” and fast “like hurrying for a bus” pace. Two tests were performed for each test using their usual walking aid and the shortest (best) result for each test was recorded.
Timepoint [4] 401439 0
Baseline, 6weeks and 13 weeks

Eligibility
Key inclusion criteria
Patients with stable CHF who have attended a disease specific heart failure rehabilitation programme
NYHA I-III
live locally
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
decompensated CHF
deemed unsafe to exercise according to ACSM guidelines
VO2peak <15 mls/kg/min
active infection
skin breakdown/ open wounds
skin sensitivity to chemicals
heat sensitive condition (eg MS) or acute inflammatory condition
urinary or faecal incontinence

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)
Potential participants who have completed the 12 week multidisciplinary rehabilitation programme and who are deemed eligible to participate in the project will be approached by the programme staff and informed about the trial.

Usual care for these patients entails referral to a community based exercise programme, prescription of a home based exercise programme or an invitation to continue at the hospital for an additional 12 weeks of maintenance exercise. As such, participation in this project will have no impact upon usual care.

Those participants who express an interest in participating in the project to the programme staff, will then be approached by the Principle Investigator at each trial site and provided with the PICF and consent form.

Consenting individuals will be randomly allocated by concealed opaque envelope method into the order in which they will undertake the two therapy blocks, i.e. either AB or BA. Randomisation will be done by a co-investigator not involved in recruitment or delivery of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted using a computer random number generator program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/01/2011
Actual
7/02/2012
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
29/11/2013
Sample size
Target
60
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20634 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 20635 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 3467 0
4029

Funding & Sponsors
Funding source category [1] 258093 0
Self funded/Unfunded
Name [1] 258093 0
Country [1] 258093 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
C/- Heart Failure Service
Level 3, James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4029
Queensland
Country
Australia
Secondary sponsor category [1] 257273 0
Hospital
Name [1] 257273 0
Princess Alexandra Hospital
Address [1] 257273 0
C/- Physiotherapy Dept
Princess Alexandra Hospital
Ipswich Rd,
Woolloongabba 4102
Queensland
Country [1] 257273 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260087 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [1] 260087 0
Gold Coast HREC
C/- Gold Coast Hospital
Nerang St
Southport 4215
Queensland
Ethics committee country [1] 260087 0
Australia
Date submitted for ethics approval [1] 260087 0
Approval date [1] 260087 0
08/11/2010
Ethics approval number [1] 260087 0
HREC/10/QGC/109

Summary
Brief summary
The proposed project is a crossover prospective design study which aims to:
1.) compare hydrotherapy versus land based exercise for patients with CHF with respect to functional capacity and quality of life.
2.) measure cardiac function during immersion and exercise in water in this patient group.

Patients will be recruited through the Heart Failure Services at Royal Brisbane and Women's Hosptal (RBWH) and Princess Alexandra Hospital (PAH). Patients will only be eligible if they have stable CHF and have successfully completed a hospital based, disease specific rehabilitation programme. Patients will be enrolled over a 6 month period and will be randomly selected into one of 2 intervention groups. All individuals will attend an exercise session once per week for 12 weeks which will include 6 weeks of land based exercise and 6 weeks of water based exercise. Whilst some will commence in the land based programme to be followed by the water based programme, the second intervention group will commence in the water based programme followed by the land based programme.

Participants will undertake an assessment on 3 occasions: before starting, after the first 6 weeks and at completion of the 12 weeks. During each assessment a number of measures will be collected. These include exercise capacity using a submaximal walking test, grip strength using a hand held dynamometer and 4 balance tests. Participants will also be asked to complete a survey regarding their perception of water based exercise.

In a small subgroup of 10 patients, cardiac function will be measured on 1 occasion. This will be done using a portable echo machine and measures will be completed in 3 positions which include: standing outside of the pool, and standing waist deep in the pool prior to and at the completion of the exercise session.

To date, no studies have compared aquatic therapy versus land based maintenance exercise in patients with CHF. If shown to be at least equally effective as traditional maintenance exercise, this may provide patients with a valid alternative that is more accomodating for those with musculoskeletal or balance issues that normally hinder land based exercise. This study will inform clinical practice and will provide valuable pilot data that will enable our research team to participate in more comprehensive trials in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31930 0
Miss Julie Adsett
Address 31930 0
C/- Heart Support Service
Royal Brisbane and Women's Hospital
Butterfield St,
Herston 4029
Brisbane,
Queensland,
Australia
Country 31930 0
Australia
Phone 31930 0
+61 7 3646 0286
Fax 31930 0
Email 31930 0
Julie.adsett@health.qld.gov.au
Contact person for public queries
Name 15177 0
Miss Julie Adsett
Address 15177 0
C/- Heart Failure Service
Royal Brisbane and Women's hospital
Level 3 James Mayne Building
Butterfield St
Herston 4029
Queensland
Country 15177 0
Australia
Phone 15177 0
+61 7 3636 0286
Fax 15177 0
Email 15177 0
julie_adsett@health.qld.gov.au
Contact person for scientific queries
Name 6105 0
Miss Julie Adsett
Address 6105 0
C/- Heart Failure Service
Royal Brisbane and Women's hospital
Level 3 James Mayne Building
Butterfield St
Herston 4029
Queensland
Country 6105 0
Australia
Phone 6105 0
+61 7 3636 0286
Fax 6105 0
Email 6105 0
julie_adsett@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be available in it's de-identified form in the study database. Hard copies will be kept in a locked cabinet for 10 years. It is not anticipated that it will be shared with others unless requested for the purposes of other research studies.
When will data be available (start and end dates)?
All data will available for 10 years. Final end date will therefore be 30/11/2023.
Available to whom?
Data will be available to the study investigators. Data will also be available upon request to other researchers.
Available for what types of analyses?
De-identified data will be available for the purposes of future meta-analyses on this topic. This data may also be used for researchers seeking clarification of analyses not specifically reported in the relevant publication.
How or where can data be obtained?
Data will be available only in de-identified format.
For the purposes of future meta-analyses, only data pertaining to the analysis will be made available.
Data can be obtained by contacting the principle investigator via email (Julie.adsett@health.qld.gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13393Ethical approval    336252-(Uploaded-30-05-2019-17-12-46)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Adsett J, Morris N, Kuys S, Hwang R, Mullins R, Kh... [More Details]
Plain language summaryNo Results of this study demonstrated that for people... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMotivators and barriers for participation in aquatic and land-based exercise training programs for people with stable heart failure: A mixed methods approach.2019https://dx.doi.org/10.1016/j.hrtlng.2018.11.004
N.B. These documents automatically identified may not have been verified by the study sponsor.