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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic lung conditions

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Respiratory

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Physical activity

Timepoint [1]

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]

Self-efficacy

Timepoint [2]

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]

Functional exercise capacity

Timepoint [1]

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]

Functional lower limb strength

Timepoint [2]

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]

Functional lower limb endurance

Timepoint [3]

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]

Health related quality of life

Timepoint [4]

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]

Respiratory symptoms

Timepoint [5]

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]

User experience of the online exercise video

Timepoint [6]

6 months post completion of pulmonary rehabilitation (end of maintenance phase)

Secondary outcome [7]

Experiences with and perspectives of the online exercise video during the maintenance phase of pulmonary rehabilitation

Timepoint [7]

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]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Balmain Hospital - Balmain

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2041 - Balmain

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Balmain Hospital

Address [2]

Country [2]

Australia

Funding source category [3]

University

Name [3]

The University of Sydney

Address [3]

Country [3]

Australia

Primary sponsor type

Government body

Name

NSW Health, Sydney Local Health District

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Sydney

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

https://www.slhd.nsw.gov.au/rpa/research/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/09/2024

Approval date [1]

01/10/2024

Ethics approval number [1]

X24-0289 & 2024/ETH01981

Summary

Brief summary

Following completion of the pulmonary rehabilitation programme, benefits in exercise capacity, quality of life, and respiratory symptoms begin to decline unless people with chronic lung conditions continue to exercise. Adherence to supervised maintenance programmes is reported to be as low as 50% at 12 months following pulmonary rehabilitation and has been attributed to barriers such as exacerbations, anxiety, lack of social support, and difficulty accessing community exercise programmes. 

Unsupervised maintenance exercise may be more accessible and less costly than supervised maintenance exercise to promote continued exercise in the home and community. Online exercise videos using minimal equipment may be a promising strategy for improving adherence to self-efficacy for exercise during the maintenance phase of pulmonary rehabilitation, but have not yet been tested in people with chronic lung conditions.  

The research questions are:
In the maintenance phase following completion of pulmonary rehabilitation, does an online exercise video increase physical activity and self-efficacy for exercise with unsupervised home exercise in people with chronic lung conditions? 
In the maintenance phase following completion of pulmonary rehabilitation, does an online exercise video maintain exercise capacity and quality of life in people with chronic lung conditions? 
in people with chronic lung conditions, what are their perspectives of using an online exercise video to pulmonary rehabilitation promote unsupervised home exercise in the maintenance phase following completion of pulmonary rehabilitation? Do perspectives vary with patient levels of self-efficacy for exercise and type of delivery of pulmonary rehabilitation?

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tiffany Dwyer

Address

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

Australia

Phone

+61 405281623

Fax

Email

[email protected]

Contact person for public queries

Name

Tiffany Dwyer

Address

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

Australia

Phone

+61 405281623

Fax

Email

[email protected]

Contact person for scientific queries

Name

Tiffany Dwyer

Address

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

Australia

Phone

+61 405281623

Fax

Email

[email protected]

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.	Type	Citation	Link	Email	Other Details	Attachment
24274	Study 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.