Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001035011
Ethics application status
Approved
Date submitted
30/08/2010
Date registered
24/11/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of community-based fitness program for people with chronic disease on health outcomes: randomised controlled trial
Scientific title
What is the efficacy of community-based follow-up versus telephone follow-up on health-related quality of life amongst people with a chronic disease who have recently completed a centre-based exercise program.
Secondary ID [1] 252589 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 258084 0
Diabetes 258085 0
Arthritis 258128 0
Chronic Low back pain 258150 0
Condition category
Condition code
Cardiovascular 258262 258262 0 0
Coronary heart disease
Musculoskeletal 258263 258263 0 0
Osteoarthritis
Inflammatory and Immune System 258264 258264 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will have previously received a 6 week health-service based exercise program, one hour (1-2 sessions per week.) They will be taken to the gym based centre 1-2 weeks after completing the health service based exercise program.
The intervention group will involve a 12 month individualized gym-based exercise program supervised by an exercise physiologist from the health service
Intervention group participants will be advised that the health professional leading their community service-based exercise program will be attending 2 hours a day Monday till Friday during the 12 month intervention to consult with them. During these 2 hour supervision times, the exercise physiologist will be supervising other clients so it is not one on one supervision. They are encouraged to attend during these supervised times. However, the client is able to attend independently during off peak times at the gym (Monday til Friday 8am - 4 pm) These participants would have had a home exercise program prescribed prior to discharge from the health service-based exercise program.
These exercise intervention sessions will be of 1 hour duration (approximately 15 min aerobic training, 40 min resistance training and 5 min flexibility and/or balance exercises) and will be held within the community based fitness centre. The exercise program will be closely supervised, multimodal, individually prescribed, based on the goals and limitations of each participant, and will be regularly progressed and adapted as necessary. In addition to resistance, aerobic and flexibility exercises, if indicated the program may also include exercises for static and dynamic balance, core stability and posture.
Participants who choose to attend this specific gym based fitness centre will be required to pay the standard casual entry fee for that centre each visit. While attending the community-based fitness centre, the execise physiologist will monitor participants’ progress and physical capacity and suggest modifications to participants’ exercise prescription. The exercise physiologist will also use motivational interviewing techniques aimed at motivating the participant to engage fully with their exercise program (both at the centre and at home) and adhere to this.
Intervention code [1] 257114 0
Treatment: Other
Intervention code [2] 257144 0
Behaviour
Comparator / control treatment
All participants will have previously received a 6 week health-service based exercise program, one hour per week once per week.

Comparator: Telephone-based follow-up / usual care.
This follow-up approach will entail participants being provided with a home exercise program at the conclusion of the health-service based exercise program to be completed independently by the client for a 12 month period. There will be no exercise physiologist attending the clients home and the supervision will be provided by the telephone follow up as stated below (5 follow-up telephone calls over the first 10 week commencing when the client receives the home exercise program)

This home exercise program intervention will be of 1 hour duration (approximately 15 min aerobic training, 40 min resistance training and 5 min flexibility and/or balance exercises) and will be completed at the clients home. The exercise program will be closely supervised, multimodal, individually prescribed, based on the goals and limitations of each participant, and will be regularly progressed and adapted as necessary. In addition to resistance, aerobic and flexibility exercises, if indicated the program may also include exercises for static and dynamic balance, core stability and posture. The frequency of the sessions will be range from (1 -4 sessions per week) depending on the clients goals as determined by the treating Exercise Physiologist.


The intervention will be 5 follow-up telephone calls over the first 10 week commencing when the client receives the home exercise program. The health professionals providing the follow-up telephone calls will use the same Health Coaching Australia model to enhance participant adherence to their program as used in the “health service staff in community-based fitness centre” intervention approach. Modifications to the home exercise program will also be made in response to participant feedback.
The initial telephone call will be 20-25 minutes in duration, subsequent telephone calls will be 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 259106 0
Health-related quality of life measured using the EQ-5D & Visual Analogue Scale (VAS) instrument
Timepoint [1] 259106 0
Baseline
3-month follow-up (via a telephone administration approach)
6-month follow-up (via a face-to-face administration approach)
9 month follow up (via telephone administration approach
12 month follow up (via a face to face admininistation
Secondary outcome [1] 265405 0
Health and Labour Questionaire
Timepoint [1] 265405 0
Baseline
3-month follow-up (via a telephone administration approach)
6-month follow-up (via a face-to-face administration approach)
9 month follow up (via telephone administration approach
12 month follow up (via a face to face admininistation
Secondary outcome [2] 265406 0
Social isolation: Measured using the Friendship Scale.
Timepoint [2] 265406 0
Baseline
3-month follow-up (via a telephone administration approach)
6-month follow-up (via a face-to-face administration approach)
9 month follow up (via telephone administration approach
12 month follow up (via a face to face admininistation
Secondary outcome [3] 265407 0
Depression and anxiety: Measured using the Hospital Anxiety and Depression Scale (Zigmond et al 1983).
Timepoint [3] 265407 0
Baseline
3-month follow-up (via a telephone administration approach)
6-month follow-up (via a face-to-face administration approach)
9 month follow up (via telephone administration approach
12 month follow up (via a face to face admininistation
Secondary outcome [4] 265408 0
Body mass index: Measured using electronic scales and measuring tape.
Timepoint [4] 265408 0
Baseline
6-month follow-up (via a face-to-face administration approach)
12 month follow up (via a face to face administration
Secondary outcome [5] 265409 0
Physical function: Measured using the 15 second sit to stand test (Haines et al 2009)
Timepoint [5] 265409 0
Baseline
6-month follow-up (via a face-to-face administration approach)
12 month follow up (via a face to face administration
Secondary outcome [6] 265412 0
6 minute walk test (Guyatt et al 1985).
Timepoint [6] 265412 0
Baseline
6-month follow-up (via a face-to-face administration approach)
12 month follow up (via a face to face administration
Secondary outcome [7] 266281 0
Health Care Utilisation
PBS and MBS data (Medicare)
Timepoint [7] 266281 0
Baseline
12 month extraction

Eligibility
Key inclusion criteria
Participants will be clients attending exercise programs at Southern Health’s Cranbourne Integrated Care Centre (Victoria). Participants in this health service-based program may suffer from a range of chronic disease diagnoses.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be if the potential participant is aged <18 years, has an acute psychiatric impairment or cognitive impairment such that the person is deemed to be unsuitable for participation in group-based exercise programs as determined by health service staff.

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)
Prior to the commencement of the patients’ discharge plan from the health service-based group exercise program, they will be informed about the project and provided with an information sheet and written consent form. A verbal explanation will also be provided by one of the investigators who will be able to answer patient’s questions. Patients who consent to participate will have the baseline assessment undertaken by one of these investigators at their discharge assessment from the health service-based group exercise program. The measures being applied for the baseline assessment overlap with those routinely administered at the discharge assessment for this program so there will be little additional burden on participants to this point.
Once baseline assessments are completed and a home exercise program prescribed, the investigator will then open a sealed, opaque envelope containing the random allocation sequence. Participants will then be provided with information relating to the intervention that they have been allocated to. The intervention will be provided as described above.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This random allocation sequence will have been developed by a different investigator than those recruiting, who has no knowledge of the patients’ baseline results or their recruitment order. This sequence will be set out in permuted blocks, and will be stratified by client main chronic disease diagnosis type (cardiovascular, musculoskeletal, diabetes, other). A computer-generated random number sequence will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257559 0
Hospital
Name [1] 257559 0
Allied Health Clinical Research Unit
Country [1] 257559 0
Australia
Primary sponsor type
Hospital
Name
Cranbourne Integrated Health Service
Address
140-154 Sladen St
Cranbourne
VIC
3977
Country
Australia
Secondary sponsor category [1] 256782 0
None
Name [1] 256782 0
Address [1] 256782 0
Country [1] 256782 0
Other collaborator category [1] 251468 0
Individual
Name [1] 251468 0
Terry Haines
Address [1] 251468 0
Allied Health Research Director
Kingston Centre
Kingston Rd
Cheltenham
VIC
3192
Country [1] 251468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259580 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 259580 0
Ethics committee country [1] 259580 0
Australia
Date submitted for ethics approval [1] 259580 0
Approval date [1] 259580 0
17/08/2010
Ethics approval number [1] 259580 0
10187L

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

Contacts
Principal investigator
Name 31585 0
Address 31585 0
Country 31585 0
Phone 31585 0
Fax 31585 0
Email 31585 0
Contact person for public queries
Name 14832 0
Paul Jansons
Address 14832 0
140-154 Sladen St
Cranbourne
VIC
3977
Country 14832 0
Australia
Phone 14832 0
+61 (0)3 5990 6139
Fax 14832 0
Email 14832 0
[email protected]
Contact person for scientific queries
Name 5760 0
Terry Haines
Address 5760 0
Kingston Centre
Kingston Rd
Cheltenham
VIC 3192
Country 5760 0
Australia
Phone 5760 0
+61 (0)3 92651774
Fax 5760 0
Email 5760 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseGym-based exercise was more costly compared with home-based exercise with telephone support when used as maintenance programs for adults with chronic health conditions: cost-effectiveness analysis of a randomised trial.2018https://dx.doi.org/10.1016/j.jphys.2017.11.010
N.B. These documents automatically identified may not have been verified by the study sponsor.