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Trial registered on ANZCTR


Registration number
ACTRN12616000357459
Ethics application status
Approved
Date submitted
16/03/2016
Date registered
18/03/2016
Date last updated
20/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing physical activity in individuals with hypertrophic cardiomyopathy: A pilot study
Scientific title
Increasing physical activity in individuals with hypertrophic cardiomyopathy: A pilot study of a program using control theory principles, motivational interviewing, telephone support, and a FitBit Charge device
Secondary ID [1] 288721 0
National Heart Foundation of Australia Vanguard Project Award number 101056
Universal Trial Number (UTN)
U1111-1180-5275
Trial acronym
PAHCM: Physical Activity in Hypertrophic CardioMyopathy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic cardiomyopathy 297959 0
Condition category
Condition code
Cardiovascular 298118 298118 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 298215 298215 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12-week intervention involves participants receiving:
A motivational interview of around 20 minutes duration, including discussion of physical activity barriers and goal setting, conducted at intervention commencement by a member of the research team, a PhD student, trained and supervised by the Primary Sponsor/Co-lead investigator who has Bachelor and PhD qualifications in psychology;
Weekly text messages, personalised by name and individually tailored on some content, and phone calls of approximately 10 minutes duration at weeks 2, 4, 8 and 12, from the same research team member, based on principles of Control Theory, to encourage participants to meet their goals and to offer personally tailored support;
A FitBit Charge device to self-monitor their physical activity. While respondents will be encouraged to wear the FitBit daily, this is purely for motivational and self-monitoring purposes, and no FitBit data will be collected for this study.
Intervention code [1] 294158 0
Behaviour
Intervention code [2] 294236 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297626 0
Time spent in discretionary (leisure-time and transport) physical activity, assessed by the International Physical Activity Questionnaire - Long format
Timepoint [1] 297626 0
12 weeks compared against baseline
Secondary outcome [1] 321610 0
Time spent in light, moderate and vigorous intensity physical activity, assessed by accelerometer worn for 7 days at each time point
Timepoint [1] 321610 0
12 weeks compared against baseline
Secondary outcome [2] 321664 0
Health-related quality of life, assessed by the Medical Outcomes Short Form-36 (SF-36v2)
Timepoint [2] 321664 0
12 weeks compared against baseline
Secondary outcome [3] 321665 0
Perceived barriers to physical activity, assessed by self-report survey based on Aaltonen et al., Int. J. Sports Med. 2012 and Booth et al., Prev Med 1997
Timepoint [3] 321665 0
12 weeks compared against baseline
Secondary outcome [4] 321666 0
Self-efficacy for physical activity, assessed by self-report based on Marcus et al., Health Psychol. 1992
Timepoint [4] 321666 0
12 weeks compared against baseline

Eligibility
Key inclusion criteria
Definite diagnosis of Hypertrophic Cardiomyopathy
Aged 18-60
Sufficient English to understand study materials
Access to a mobile telephone
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major co-morbidities e.g. morbid obesity, or other reason for which treating cardiologist recommends against participation
Pregnancy

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Prior data from our preliminary study showed the mean duration of participation in moderate-vigorous physical activity in 187 Hypertrophic Cardiomyopathy patients was 71 mins per week (SD = 126). Based on an increase to the recommended minimum of 150 mins per week, we will need at least 22 participants to be able to reject the null hypothesis that the response difference is zero with power of 80% and type 1 error probability of 0.05. We will analyse intervention effects by comparing 12-week follow-up with baseline scores using paired t-tests or equivalent non-parametric tests should assumptions for parametric tests not be met.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2016
Actual
20/05/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
21/04/2017
Date of last data collection
Anticipated
Actual
31/07/2017
Sample size
Target
22
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5414 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 12904 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 293078 0
Charities/Societies/Foundations
Name [1] 293078 0
National Heart Foundation of Australia
Country [1] 293078 0
Australia
Primary sponsor type
Individual
Name
Kylie Ball
Address
Institute for Physical Activity and Nutrition
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 291859 0
Individual
Name [1] 291859 0
Christopher Semsarian
Address [1] 291859 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country [1] 291859 0
Australia
Other collaborator category [1] 278893 0
Individual
Name [1] 278893 0
Jo Sweeting
Address [1] 278893 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country [1] 278893 0
Australia
Other collaborator category [2] 278894 0
Individual
Name [2] 278894 0
Jodie Ingles
Address [2] 278894 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country [2] 278894 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294586 0
Research Ethics and Governance Office, Royal Prince Alfred Hospital
Ethics committee address [1] 294586 0
Research Ethics and Governance Office,
Royal Prince Alfred Hospital,
Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 294586 0
Australia
Date submitted for ethics approval [1] 294586 0
26/05/2015
Approval date [1] 294586 0
15/06/2015
Ethics approval number [1] 294586 0
X15-0205 & HREC/15/RPAH/270

Summary
Brief summary
This project aims to assess the effectiveness and feasibility of a program to increase physical activity in individuals with the most common inherited heart disease, Hypertrophic Cardiomyopathy (HCM). A sample of 22 patients will be recruited from the HCM and Genetic Heart Disease clinics at the Royal Prince Alfred Hospital. They will undertake a survey to establish baseline measurements of moderate-vigorous physical activity (MVPA, measured by IPAQ-Long), mental and physical health (SF-36v2), and self-efficacy and barriers to physical activity; and wear an accelerometer for 7 days. A motivational interview, including discussion of barriers and goal setting, will be conducted with a member of the research team. Participants will also be provided with a FitBit Charge device to self-monitor their physical activity.
Over the following study period of 12 weeks, participants will receive phone calls (weeks 2, 4, 8 and 12) and weekly text messages from the research team to encourage them to meet their goals and to offer support that is personalised and consistent with Control Theory principles.
At the completion of the intervention, participants will undergo the same evaluation as at baseline, and also provide process evaluation feedback regarding the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64250 0
Prof Christopher Semsarian
Address 64250 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country 64250 0
Australia
Phone 64250 0
+61 2 95656195
Fax 64250 0
Email 64250 0
[email protected]
Contact person for public queries
Name 64251 0
Prof Christopher Semsarian
Address 64251 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country 64251 0
Australia
Phone 64251 0
+61 2 95656195
Fax 64251 0
Email 64251 0
[email protected]
Contact person for scientific queries
Name 64252 0
Prof Christopher Semsarian
Address 64252 0
Centenary Institute
Locked Bag 6, Newtown NSW 2042.
Country 64252 0
Australia
Phone 64252 0
+61 2 95656195
Fax 64252 0
Email 64252 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
EmbaseA Control Theory-Based Pilot Intervention to Increase Physical Activity in Patients With Hypertrophic Cardiomyopathy.2018https://dx.doi.org/10.1016/j.amjcard.2018.05.023
N.B. These documents automatically identified may not have been verified by the study sponsor.