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Trial registered on ANZCTR


Registration number
ACTRN12624001315505
Ethics application status
Approved
Date submitted
14/10/2024
Date registered
30/10/2024
Date last updated
30/10/2024
Date data sharing statement initially provided
30/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an exercise video on physical activity and self-efficacy with unsupervised home exercise following pulmonary rehabilitation
Scientific title
Pilot study investigating the effects of an exercise video on physical activity and self-efficacy with unsupervised home exercise in the maintenance phase following completion of pulmonary rehabilitation in people with chronic lung disease
Secondary ID [1] 313176 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lung conditions 335461 0
Condition category
Condition code
Respiratory 332020 332020 0 0
Chronic obstructive pulmonary disease
Respiratory 332021 332021 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online exercise video demonstrating a typical session of pulmonary rehabilitation. The video consists of a warm-up, aerobic lower limb exercise using minimal equipment (eg, marching on the spot), aerobic upper limb exercise using minimal equipment (eg, unsupported upper limb exercises with free weights), lower and upper limb resistance exercises using minimal equipment (eg, sit to stand from a chair, bicep curls using elastic resistance bands), and a cool down. The video is approximately 40 minutes in duration. Participants will be encouraged to exercise at home using the video at least 3-5 times/week in the 6-month maintenance phase after completion of a pulmonary rehabilitation program. Participants will use an online survey form to record whether they have completed any exercise sessions during the week, how many exercise sessions, for how many sessions they used the online exercise video, and any reasons for not engaging with exercise (e.g., unwell, travelling, not able to access the online exercise video).
Intervention code [1] 329752 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339623 0
Physical activity
Timepoint [1] 339623 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Primary outcome [2] 339624 0
Self-efficacy
Timepoint [2] 339624 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [1] 440657 0
Functional exercise capacity
Timepoint [1] 440657 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [2] 440658 0
Functional lower limb strength
Timepoint [2] 440658 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [3] 440659 0
Functional lower limb endurance
Timepoint [3] 440659 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [4] 440660 0
Health related quality of life
Timepoint [4] 440660 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [5] 440661 0
Respiratory symptoms
Timepoint [5] 440661 0
During pulmonary rehabilitation (midway through program); at completion of pulmonary rehabilitation; 6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [6] 440662 0
User experience of the online exercise video
Timepoint [6] 440662 0
6 months post completion of pulmonary rehabilitation (end of maintenance phase)
Secondary outcome [7] 440663 0
Experiences with and perspectives of the online exercise video during the maintenance phase of pulmonary rehabilitation
Timepoint [7] 440663 0
6 months post completion of pulmonary rehabilitation (end of maintenance phase)

Eligibility
Key inclusion criteria
Adults with a chronic lung condition who are in their final two weeks of a pulmonary rehabilitation program;
Clinically stable and appropriate for discharge from a pulmonary rehabilitation program at time of initial data collection (i.e., including no change in respiratory medications or worsening of respiratory symptoms in last 2 weeks);
Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to perform unsupervised and independent moderate intensity exercise (e.g., severe cognitive impairment, high falls risk, other comorbidities that would make remote exercise unsafe);
No internet access in their home (either via phone or computer), so unable to watch the online exercise video.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Demographic information will be reported as mean and standard deviation for continuous variables, and as counts and percentages for categorical variables. Changes in physical activity, self-efficacy for exercise, functional exercise capacity, functional lower limb strength, health-related quality of life, and symptoms over time (i.e., from during pulmonary rehabilitation to completion of pulmonary rehabilitation to 6 months post completion of pulmonary rehabilitation) will be analysed using paired t-tests. Qualitative data from the user experience survey and from the semi-structured interviews will be analysed descriptively and using the Theoretical Framework of Acceptability, respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27214 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 27215 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 43296 0
2050 - Camperdown
Recruitment postcode(s) [2] 43297 0
2041 - Balmain

Funding & Sponsors
Funding source category [1] 317625 0
Hospital
Name [1] 317625 0
Royal Prince Alfred Hospital
Country [1] 317625 0
Australia
Funding source category [2] 317684 0
Hospital
Name [2] 317684 0
Balmain Hospital
Country [2] 317684 0
Australia
Funding source category [3] 317685 0
University
Name [3] 317685 0
The University of Sydney
Country [3] 317685 0
Australia
Primary sponsor type
Government body
Name
NSW Health, Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319937 0
University
Name [1] 319937 0
The University of Sydney
Address [1] 319937 0
Country [1] 319937 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316325 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316325 0
Ethics committee country [1] 316325 0
Australia
Date submitted for ethics approval [1] 316325 0
04/09/2024
Approval date [1] 316325 0
01/10/2024
Ethics approval number [1] 316325 0
X24-0289 & 2024/ETH01981

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

Contacts
Principal investigator
Name 137526 0
Dr Tiffany Dwyer
Address 137526 0
Level 7 D18 Susan Wakil Health Building ,Sydney School of Health Sciences, Faculty of Medicine and Health. THE UNIVERSITY OF SYDNEY. Camperdown NSW 2050.
Country 137526 0
Australia
Phone 137526 0
+61 405281623
Fax 137526 0
Email 137526 0
tiffany.dwyer@sydney.edu.au
Contact person for public queries
Name 137527 0
Tiffany Dwyer
Address 137527 0
Level 7 D18 Susan Wakil Health Building ,Sydney School of Health Sciences, Faculty of Medicine and Health. THE UNIVERSITY OF SYDNEY. Camperdown NSW 2050.
Country 137527 0
Australia
Phone 137527 0
+61 405281623
Fax 137527 0
Email 137527 0
tiffany.dwyer@sydney.edu.au
Contact person for scientific queries
Name 137528 0
Tiffany Dwyer
Address 137528 0
Level 7 D18 Susan Wakil Health Building ,Sydney School of Health Sciences, Faculty of Medicine and Health. THE UNIVERSITY OF SYDNEY. Camperdown NSW 2050.
Country 137528 0
Australia
Phone 137528 0
+61 405281623
Fax 137528 0
Email 137528 0
tiffany.dwyer@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24274Study protocol    388617-(Uploaded-14-10-2024-11-58-48)-PR maintenance ex video_Research Protocol_v2_2024_09_23_clean.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.