ANZCTR - Registration

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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 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]

no secondary ID

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Heart Failure

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Water versus land exercise

Control group

Active

Outcomes

Primary outcome [1]

Six minute walk test - change in walking distance

Timepoint [1]

baseline, 6 weeks, 13 weeks

Secondary outcome [1]

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]

baseline, 6 weeks, 13 weeks

Secondary outcome [2]

Quality of Life - using the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)

Timepoint [2]

baseline, 6 weeks, 13 weeks

Secondary outcome [3]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4029

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Hospital

Name [1]

Princess Alexandra Hospital

Address [1]

C/- Physiotherapy Dept
Princess Alexandra Hospital
Ipswich Rd,
Woolloongabba 4102
Queensland

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Health Service District Human Research Ethics Committee

Ethics committee address [1]

Gold Coast HREC
C/- Gold Coast Hospital
Nerang St
Southport 4215
Queensland

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/11/2010

Ethics approval number [1]

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

Miss Julie Adsett

Address

C/- Heart Support Service
Royal Brisbane and Women's Hospital
Butterfield St,
Herston 4029
Brisbane,
Queensland,
Australia

Country

Australia

Phone

+61 7 3646 0286

Fax

Julie.adsett@health.qld.gov.au

Contact person for public queries

Name

Julie Adsett

Address

C/- Heart Failure Service
Royal Brisbane and Women's hospital
Level 3 James Mayne Building
Butterfield St
Herston 4029
Queensland

Country

Australia

Phone

+61 7 3636 0286

Fax

julie_adsett@health.qld.gov.au

Contact person for scientific queries

Name

Julie Adsett

Address

C/- Heart Failure Service
Royal Brisbane and Women's hospital
Level 3 James Mayne Building
Butterfield St
Herston 4029
Queensland

Country

Australia

Phone

+61 7 3636 0286

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
13393	Ethical approval					336252-(Uploaded-30-05-2019-17-12-46)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Motivators and barriers for participation in aquatic and land-based exercise training programs for people with stable heart failure: A mixed methods approach.	2019	https://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.

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