Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001102763p
Ethics application status
Submitted, not yet approved
Date submitted
3/08/2022
Date registered
10/08/2022
Date last updated
10/08/2022
Date data sharing statement initially provided
10/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance Exercise Strength Training (BEST) at Home exercise program for people with chronic obstructive pulmonary disease (COPD) who access virtual care.
Scientific title
Efficacy of a home-based balance and strength training program (BEST at Home) on balance, strength and fear of falling in people with chronic obstructive pulmonary disease (COPD) who access a virtual care program.
Secondary ID [1] 307620 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a translational study of ACTRN12615000865516, where the intervention program has been adapted for people with chronic obstructive pulmonary disease who access a virtual care program.

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 327098 0
Falls 327099 0
Impaired balance 327100 0
Condition category
Condition code
Injuries and Accidents 324245 324245 0 0
Fractures
Musculoskeletal 324246 324246 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 324247 324247 0 0
Physiotherapy
Respiratory 324248 324248 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a modified version of the BEST at Home lower limb program which is a home-based exercise program for the lower limb which found a significant reduction in fear of falling and improvement in gait speed.(Bates e al 2018, 2022). The BEST at Home program is based on the Otago Exercise Program, which has been found to reduce rates of falls and injurious falls (Campbell et al 1997, 1999).

The lower limb exercise program includes balance and strength exercises for example sit to stand, semi squats from a standing position, calf raises, toe raises, sideways walking, backwards walking and one leg stand. The exercise instruction will be delivered face to face by an experienced pulmonary rehabilitation physiotherapist in two small group sessions of one hour duration with approximately 3-5 participants per group. The level of exercise intensity will be low-moderate, and will be assessed using a Borg Rating of Perceived Exertion (RPE) scale. Exercise instruction will occur at weeks 1 and 13 at a local Community Health Centre, with follow-up video calls from the physiotherapist at weeks 2, 4 and 8. The video calls will cover adherence to home exercises, progress, breathing strategies and any questions a participant may have regarding the exercises. The video calls will be approximately 20 minutes in duration.

Participants will be encouraged to perform the set of exercises three times per week at home for a period of six months. The set of exercises should take 30 minutes to complete. The weights to be used at the beginning of the program and progression of exercise intensity will be individualised and determined by the physiotherapist. The exercises are to be completed with good technique and control. Once exercises can be performed comfortably, they are progressed by increasing weight, increasing repetitions and/or decreasing the support.

Participants will be provided with a home exercise manual (produced by the research team) which contains clear pictures and descriptions of the exercises (from the original Otago Exercise Program), a booklet about preventing falls (titled Staying active and on your feet, by NSW Health, 2010) and a calendar to record when they complete the exercises and any falls they may have. Participants will receive education on managing shortness of breath and exercise anxiety with COPD at the first exercise instruction session.

Adherence will be monitored by attendance at exercise and measurement sessions, along with a paper calendar to record when they complete the exercises (which will be returned monthly using reply paid envelopes).
Intervention code [1] 324067 0
Prevention
Intervention code [2] 324068 0
Lifestyle
Intervention code [3] 324205 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332067 0
Fear of falling will be assessed with the short version of the Falls Efficacy Scale-International (FES-I)
Timepoint [1] 332067 0
Baseline and 6 months post intervention commencement
Primary outcome [2] 332210 0
Strength and balance will be assessed with the Short Physical Performance Battery (SPPB), which is a composite measure including sit to stand, timed walk and standing balance.
Timepoint [2] 332210 0
Baseline and 6 months post intervention commencement
Secondary outcome [1] 412048 0
Balance will be assessed with the alternate step test
Timepoint [1] 412048 0
Baseline and 3 and 6 months post intervention commencement
Secondary outcome [2] 412049 0
Balance will be assessed with standing balance test (consisting of feet apart, feet together, semi-tandem, tandem and single leg stance)
Timepoint [2] 412049 0
Baseline and 3 and 6 months post intervention commencement
Secondary outcome [3] 412050 0
Lower limb strength will be assessed with a quadriceps strength test by a digital weight scale
Timepoint [3] 412050 0
Baseline and 3 and 6 months post intervention commencement
Secondary outcome [4] 412051 0
Gait speed will be assessed with the time taken to complete a 4 metre walk.
Timepoint [4] 412051 0
Baseline and 3 and 6 months post intervention commencement
Secondary outcome [5] 412052 0
Lower limb strength will be assessed with the time taken to complete a sit to stand (5 times).
Timepoint [5] 412052 0
Baseline and 3 and 6 months post intervention commencement
Secondary outcome [6] 412549 0
Number of falls
Timepoint [6] 412549 0
Number of falls reported in the 6 months prior to baseline via study-specific questionnaire and the number of falls recorded on monthly calendars during the 6 month study period.
Secondary outcome [7] 412687 0
Fear of falling will be assessed with the short version of the Falls Efficacy Scale-International (FES-I)
Timepoint [7] 412687 0
Baseline and 3 months post intervention commencement
Secondary outcome [8] 412688 0
Strength and balance will be assessed with the Short Physical Performance Battery (SPPB), which is a composite measure including sit to stand, timed walk and standing balance.
Timepoint [8] 412688 0
Baseline and 3 months post intervention commencement

Eligibility
Key inclusion criteria
All diagnosed COPD clients currently accessing Illawarra Shoalhaven Local Health District virtually enhanced community care (VeCC) will be invited to participate in the project if they are able to walk 10 metres with or without a walking aid.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have dementia or other cognitive limitations, or insufficient English language skills or a progressive neurological disease or medical condition precluding exercise.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be conducted using Stata. Paired sample t-tests for the difference in pre-post means will be used to describe changes from baseline to 3-months and baseline to 6-months for continuous variables and chi-squared test will be used for categorical variables.
Participant adherence and retention will be recorded.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311884 0
Government body
Name [1] 311884 0
National Health and Medical Research Council
Country [1] 311884 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Illawarra Shoalhaven Local Health District, Health Promotion Service
Level 1, 67-71 King St, Warrawong NSW 2502
Country
Australia
Secondary sponsor category [1] 313363 0
University
Name [1] 313363 0
The University of Sydney
Address [1] 313363 0
School of Public Health
The University of Sydney, NSW 2006
Country [1] 313363 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311319 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Human Research Ethics Committee
Ethics committee address [1] 311319 0
Ethics committee country [1] 311319 0
Australia
Date submitted for ethics approval [1] 311319 0
18/07/2022
Approval date [1] 311319 0
Ethics approval number [1] 311319 0

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

Contacts
Principal investigator
Name 120698 0
Mrs Michelle Kershaw
Address 120698 0
Illawarra Shoalhaven Local Health District, Health Promotion Service
67-71 King St, Warrawong NSW 25255
Postal address: Locked Bag 9, Wollongong 2500
Country 120698 0
Australia
Phone 120698 0
+61 2 42216728
Fax 120698 0
Email 120698 0
[email protected]
Contact person for public queries
Name 120699 0
Michelle Kershaw
Address 120699 0
Illawarra Shoalhaven Local Health District, Health Promotion Service
67-71 King St, Warrawong NSW 25255
Postal address: Locked Bag 9, Wollongong 2500
Country 120699 0
Australia
Phone 120699 0
+61 2 42216728
Fax 120699 0
Email 120699 0
[email protected]
Contact person for scientific queries
Name 120700 0
Amanda Bates
Address 120700 0
Illawarra Shoalhaven Local Health District, Health Promotion Service
67-71 King St, Warrawong NSW 25255
Postal address: Locked Bag 9, Wollongong 2500
Country 120700 0
Australia
Phone 120700 0
+61 2 42216786
Fax 120700 0
Email 120700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified primary outcome data will be available once planned publications are complete.
When will data be available (start and end dates)?
Data will be available once our planned publications are published and available for five years after publication.
Available to whom?
Subscribers to the journal publications.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Via the publication journal or via Amanda Bates by email on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16695Clinical study report    Following study completed and successful publicati... [More Details]
16696Ethical approval    Will be uploaded once ethical approval is granted.



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.