Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001411336
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
5/10/2017
Date last updated
5/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Aquatic "water-based" exercise on exercise capacity and quality of life in people with Chronic Heart Failure and/or a chronic respiratory disease
Scientific title
The effect of Aquatic Exercise Training on Exercise Capacity and Health Related Quality of Life in people with Chronic Heart Failure and/or a Chronic Respiratory Disease: A Pilot Study
Secondary ID [1] 292897 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic respiratory disease 304743 0
Chronic heart failure 304744 0
Condition category
Condition code
Respiratory 304073 304073 0 0
Chronic obstructive pulmonary disease
Cardiovascular 304074 304074 0 0
Other cardiovascular diseases
Respiratory 304282 304282 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will exercise in a hydrotherapy pool, heated to 32-33 degrees. The exercise sessions will last approximately 45 minutes and will be similar in structure to traditional land-based pulmonary rehabilitation classes. The participants will complete a variety of aerobic and strengthening exercises in the water, aiming to achieve a moderate level of breathlessness or fatigue as determined by the modified Borg Scale. The sessions will run twice/weekly for eight weeks and will be supervised by two experienced physiotherapists. Exercise sessions will be group classes with a maximum of ten attendees each session. Intervention adherence rates will be monitored by documenting which participants have attended each session and each participants exercise routine will be documented on a recording sheet each session. Exercises will be progressed gradually based on participants' symptoms and willingness. No particular strategies are being employed to increase adherence or participation apart from general encouragement to attend and education about signs the participants are ready to progress
Intervention code [1] 299133 0
Rehabilitation
Comparator / control treatment
No control group- pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303394 0
Distance walked in a six-minute walk test
Timepoint [1] 303394 0
At baseline and at the end of eight week exercise program
Secondary outcome [1] 338825 0
Health related quality of life measured by St George Respiratory Questionnaire
Timepoint [1] 338825 0
At baseline and at the end of eight week exercise program
Secondary outcome [2] 338826 0
Levels of Anxiety, measured using the Anxiety domain of the Hospital Anxiety and Depression Scale
Timepoint [2] 338826 0
At baseline and at the end of eight week exercise program
Secondary outcome [3] 339351 0
Levels of Depression, measured using the Depression domain of the Hospital Anxiety and Depression Scale
Timepoint [3] 339351 0
At the end of eight week exercise program
Secondary outcome [4] 339352 0
Functional quadriceps strength measured by the Five Sit-to-Stand test
Timepoint [4] 339352 0
At baseline and at the end of eight week exercise program
Secondary outcome [5] 339353 0
Participant (both patient and physiotherapist) satisfaction measured with purpose designed qualitative questionnaire
Timepoint [5] 339353 0
At the end of eight week exercise program

Eligibility
Key inclusion criteria
People with a confirmed diagnosis of chronic heart failure and/or a chronic respiratory disease, including but not limited to Chronic Obstructive Pulmonary Disease, bronchiectasis and interstitial lung disease
Have completed an initial assessment with the CDCRS exercise rehabilitation program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• have had an interventional cardiac procedure in the eight weeks prior or an exacerbation of their CHF and/or chronic respiratory disease in the two weeks prior to assessment;
• unstable CHF or those who are symptomatic at rest (New York Heart Association Class IV);
• have medical contraindications to exercise training in the water including unstable epilepsy, open wounds which cannot be contained by waterproof dressing, urinary or faecal incontinence;
• participation in any supervised exercise training within the last 12 months;
• cognitive impairment that would limit their ability to participate safely in a group exercise environment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/10/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9034 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 9035 0
Ryde Hospital - Eastwood
Recruitment hospital [3] 9036 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 17515 0
2065 - St Leonards
Recruitment postcode(s) [2] 17516 0
2122 - Eastwood
Recruitment postcode(s) [3] 17517 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 297528 0
Hospital
Name [1] 297528 0
Chronic disease community rehabilitation service, Macquarie Hospital
Country [1] 297528 0
Australia
Primary sponsor type
Individual
Name
Meredith King
Address
Chronic Disease Community Rehabilitation Service, Macquarie Hospital.
The Lodge, corner Twin and Badajoz Road, North Ryde, NSW 2113
Country
Australia
Secondary sponsor category [1] 296534 0
Individual
Name [1] 296534 0
Dr Sally Wootton
Address [1] 296534 0
Chronic Disease Community Rehabilitation Service, Macquarie Hospital.
The Lodge, corner Twin and Badajoz Road, North Ryde, NSW 2113
Country [1] 296534 0
Australia
Other collaborator category [1] 279757 0
Individual
Name [1] 279757 0
Ms Jillian Chua
Address [1] 279757 0
Graythwaite Rehabilitation Centre, Ryde Hospital.
Fourth Avenue, Eastwood, NSW, 2112.
Country [1] 279757 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298624 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 298624 0
Level 13, Kolling Building, Royal North Shore Hospital, St Leonards, NSW, 2065
Ethics committee country [1] 298624 0
Australia
Date submitted for ethics approval [1] 298624 0
20/04/2017
Approval date [1] 298624 0
02/08/2017
Ethics approval number [1] 298624 0

Summary
Brief summary
This study will investigate the effect of an aquatic or water-based exercise program on exercise capacity and quality of life in people with chronic heart failure and/or a chronic respiratory disease.
People will be recruited to the study after their initial assessment with the Chronic Disease Community Rehabilitation Service at Royal North Shore, Ryde and Hornsby Ku-rin-gai Hospitals.
The participants will attend a 45-60 minute exercise session in the hydrotherapy pool at the Graythwaite rehabilitation centre twice/weekly for eight weeks that focuses on endurance, lower limb and upper limb strengthening in a similar manner to traditional pulmonary and heart failure gym classes.
Outcome measures including six-minute walk distance, leg strength (measured by five sit to stand test), quality of life and levels of anxiety and depression will be retrieved from participants medical record after completion of the program as these measures are routinely performed as part of the CDCRS service.
An additional qualitative satisfaction survey will be completed by all participants at the end of the program to evaluate the new program. All staff involved in the program will also complete a qualitative survey at the end of their involvement with the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77690 0
Ms Meredith King
Address 77690 0
Chronic Disease Community Rehabilitation Service, Macquarie Hospital
The Lodge, corner Twin and Badajoz Road, North Ryde, NSW, 2113
Country 77690 0
Australia
Phone 77690 0
+61 2 88774041
Fax 77690 0
Email 77690 0
[email protected]
Contact person for public queries
Name 77691 0
Ms Meredith King
Address 77691 0
Chronic Disease Community Rehabilitation Service, Macquarie Hospital.
The Lodge, corner Twin and Badajoz Road, North Ryde, NSW, 2113
Country 77691 0
Australia
Phone 77691 0
+ 61 2 88774041
Fax 77691 0
Email 77691 0
[email protected]
Contact person for scientific queries
Name 77692 0
Ms Meredith King
Address 77692 0
Chronic Disease Community Rehabilitation Service, Macquarie Hospital.
The Lodge, corner Twin and Badajoz Road, North Ryde, NSW, 2113
Country 77692 0
Australia
Phone 77692 0
+61 2 88774041
Fax 77692 0
Email 77692 0
[email protected]

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

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