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Trial registered on ANZCTR


Registration number
ACTRN12611000890932
Ethics application status
Approved
Date submitted
19/08/2011
Date registered
19/08/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
'Physical Activity at Home (PAAH)', Evaluation of a group versus home based physical activity program in community dwelling middle aged adults.
Scientific title
In middle-aged community dwelling adults is a physiotherapy-led home based physical activity program more effective than a community group based physical activity program in terms of long term physical activity adherance, health benefits and cost?
Secondary ID [1] 262876 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PAAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 270592 0
type 2 diabetes 270593 0
obesity 270594 0
high blood pressure 270596 0
lipid disorders 270597 0
osteoporosis 270598 0
colon cancer 270602 0
breast cancer 270603 0
depression 270604 0
anxiety 270605 0
Condition category
Condition code
Public Health 270764 270764 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home based intervention.
Baseline outcome measures were taken in participants homes eliminating a number of barriers to physical activity adoption. Participants were encouraged to invite a support person to attend. After baseline measures were completed motivational interviewing was used to devise a physical activity program. A physiotherapist discussed type, frequency, intensity, duration, benefits, barriers, goals, self-monitoring and progression of physical activity aiming to achieve 30 minutes of moderate intensity physical activity on most days of the week eventually. Participants were contacted by a physiotherapist via phone providing advice and support 2 weeks after the initial assessment and them monthly over a six month period, a total of approximately 6 phone calls.
Intervention code [1] 269228 0
Prevention
Intervention code [2] 269229 0
Lifestyle
Intervention code [3] 269230 0
Behaviour
Comparator / control treatment
Group exercise program.
This group acted as an active control, replicating standard physical activity options provided in the community. Participants attended a local YMCA for their baseline measures. Participants had a choice of times for the group based exercise program which were all during business hours. These sessions were run by a YMCA fitness instructor at the YMCA once a week, for 60 minutes, over 6 months. The exercise program involved upper and lower body strengthening exercises, gross motor skill training and aerobic fitness training. Participants were encouraged to increase their physical activity levels outside of the group sessions, aiming to achieve 30 minutes of moderate intensity exercise most days but individual physical activity programs were not specifically designed for this group.
Control group
Active

Outcomes
Primary outcome [1] 279460 0
Physical activity adherence assessed via exercise diaries. Participants were encouraged to record any exercise completed in the exercise diary and return the diaries in the provided reply paid envelope at the end of the month. Exercise completed will be compared to exercise prescribed to determine adherence.
Timepoint [1] 279460 0
6 (end of intervention period), 12, 18 and 24 months.
Primary outcome [2] 279461 0
Physical activity adherence or 'sufficient' physical activty via the Active Australia Survey. All particpants will complete this survey at the below timepoints.
Timepoint [2] 279461 0
Baseline, 6(end of intervention period), 12, 18 and 24 months.
Primary outcome [3] 279462 0
Physical activity adherence via the Actigraph GT1M accelerometer. All particpants will wear the accelerometer for a week in the month prior to the data collection points. The Active Australia Survey will be completed at the end of this week.
Timepoint [3] 279462 0
6 (end of the intervention period), 12, 18 and 24 months.
Secondary outcome [1] 287690 0
Aerobic capacity via the 2 minute step test.
Timepoint [1] 287690 0
Baseline, 6 (end of the intervention period), 12, 18 and 24 months.
Secondary outcome [2] 287691 0
Quality of life via the SF-12 quality of life survey.
Timepoint [2] 287691 0
Baseline, 6 (end of the intervention period), 12, 18 and 24 months.
Secondary outcome [3] 287692 0
Disease biomarkers via waist circumference (cm), waist:hip ratio, body mass index (kg/m2) and blood pressure (mmHg).
Timepoint [3] 287692 0
Baseline, 6(end of the intervention period), 12, 18 and 24 months.

Eligibility
Key inclusion criteria
1. 50-65 years old.
2. Sedentary, that is, no participation in regular moderate or vigorous physical activity for 30 minutes 2 or more times a week for at least 6 months.
3. No serious medical conditions, such as unstable angina, uncontrolled hypertension, diagnosed or hospitalised with chest pain, heart attack or heart surgery in the past 6 months.
4. No servere functional impairments due to multiple medical or psychiatric diseases.
5. Not planning to move from the area within 2 years.
6. Only one person per household was eligible.
7. English speaking and appropriate cognitive skills to provide informed consent and actively engage in a physical activity program.
8. Medical screening was undertaken using the Sports Medicine Australia (SMA) Pre-Exercise Screening System. If a participant answered 'yes' to any of the SMA screening questions, they were asked to attend their local medical officer to receive medical clearance before they were included in the study.
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.See the above inclusion criteria.
2. Resting systolic blood pressure > 200mmHg, diastolic blood pressure > 100mmHg, resting heart rate > 100 bpm.

Study design
Purpose of the study
Prevention
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
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
16/02/2011
Actual
16/02/2011
Date of last participant enrolment
Anticipated
16/04/2011
Actual
16/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4369 0
2606

Funding & Sponsors
Funding source category [1] 269699 0
University
Name [1] 269699 0
University of Canberra Research Student Funds
Country [1] 269699 0
Australia
Primary sponsor type
Individual
Name
Nicole Freene
Address
Faculty of Health
University of Canberra
ACT
2601
Country
Australia
Secondary sponsor category [1] 268735 0
Individual
Name [1] 268735 0
Gordon Waddington
Address [1] 268735 0
Physiotherapy
Faculty of Health
University of Canberra
ACT
2601
Country [1] 268735 0
Australia
Secondary sponsor category [2] 268736 0
Individual
Name [2] 268736 0
Wendy Chesworth
Address [2] 268736 0
Physiotherapy
Faculty of Health
University of Canberra
ACT
2601
Country [2] 268736 0
Australia
Secondary sponsor category [3] 268737 0
Individual
Name [3] 268737 0
Rachel Davey
Address [3] 268737 0
Centre for Reserach & Action in Public Health
Faculty of Health
University of Canberra
ACT
2601
Country [3] 268737 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271662 0
University of Canberra Committee for Ethics in Human Research
Ethics committee address [1] 271662 0
University of Canberra
ACT
2601
Ethics committee country [1] 271662 0
Australia
Date submitted for ethics approval [1] 271662 0
Approval date [1] 271662 0
20/11/2009
Ethics approval number [1] 271662 0
09-97

Summary
Brief summary
The aim of this study is to evaluate a new evidence based model for increasing the adoption and maintenance of physical activity in sedentary community dwelling middle aged individuals. Specifically targeting those individulas who are less likely to adopt and maintain exercise as they do not normally access the currently available community group exercise programs.


We hypothesize that
(i) There are a large number of individuals in the community aged 50-65 years who are not interested in group exercise, the common method used to increase the population's level of physical activity.
(ii) A proportion of this group would commence exercising if an alternative method of increasing physcial activity was available, such as a home based approach.
(iii) The home based program would produce health benfits equivalent to those seen in the group based exercise program for sedentary adults 50-65 years old.
(iv) Those that commence the home based program are more likely to continue with an increase in physical activity in the long term, as compared to a group based program.
(v) A home based approach to increasing physical activity with minimal support is more cost effective than a group based intervention, taking into consideration long term physical activity maintenance.
Trial website
Trial related presentations / publications
Freene N, Waddington G, Chesworth W, Davey R, Cochrane T (2013). Community group exercise versus physiotherapist-led home-based physical activity program: barriers, enablers and preferences in middle-aged adults. Physiotherapy Theory and Practice 0(0), 1-9. DOI: doi:10.3109/09593985.2013.816894.

Freene N, Waddington G, Chesworth W, Davey R, Cochrane T (2013). Physiotherapist-led home-based physical activity program versus community group exercise for middle-aged adults: Quasi-experimental comparison. Open Journal of Preventive Medicine 3, 229-237. DOI: 10.4236/ojpm.2013.32031.

Freene N, Waddington G, Chesworth W, Davey R, Cochrane T (2013). Validating two self-report physical activity measures in middle-aged adults completing a group exercise or home-based physical activity program. Journal of Science and Medicine in Sport(0) DOI: http://dx.doi.org/10.1016/j.jsams.2013.11.002.

Freene N, Waddington G, Chesworth W, Davey R, Goss J (2011). 'Physical activity at home (PAAH)', evaluation of a group versus home based physical activity program in community dwelling middle aged adults: rationale and study design. BMC Public Health 11, 883-883.

Freene N, Waddington G, Davey R, Cochrane T (2013). Longitudinal comparison of a physiotherapist-led, home-based and group-based program for increasing physical activity in community-dwelling middle-aged adults. Australian Journal Of Primary Health.
Public notes

Contacts
Principal investigator
Name 33044 0
Ms Nicole Freene
Address 33044 0
Faculty of Health
University of Canberra
BRUCE
ACT 2601
Country 33044 0
Australia
Phone 33044 0
+61 2 6201 2638
Fax 33044 0
Email 33044 0
[email protected]
Contact person for public queries
Name 16291 0
Nicole Freene
Address 16291 0
Faculty of Health
University of Canberra
ACT
2601
Country 16291 0
Australia
Phone 16291 0
+61 2 6201 2638
Fax 16291 0
Email 16291 0
[email protected]
Contact person for scientific queries
Name 7219 0
Nicole Freene
Address 7219 0
Faculty of Health
University of Canberra
ACT
2601
Country 7219 0
Australia
Phone 7219 0
+61 2 6201 2638
Fax 7219 0
Email 7219 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
Embase'Physical activity at home (PAAH)', evaluation of a group versus home based physical activity program in community dwelling middle aged adults: rationale and study design.2011
EmbaseLongitudinal comparison of a physiotherapist-led, home-based and group-based program for increasing physical activity in community-dwelling middle-aged adults.2015https://dx.doi.org/10.1071/PY13114
N.B. These documents automatically identified may not have been verified by the study sponsor.