Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000628741
Ethics application status
Approved
Date submitted
11/08/2021
Date registered
28/04/2022
Date last updated
28/04/2022
Date data sharing statement initially provided
28/04/2022
Date results information initially provided
28/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a community based supervised exercise programme on hospice patients with end stage Chronic Obstructive Pulmonary Disease improve physical performance, quality of life and physical activity? A pilot study
Scientific title
The impact of a community-based supervised exercise programme on hospice patients with end stage Chronic Obstructive Pulmonary Disease on physical performance, quality of life and physical activity; a pilot study
Secondary ID [1] 305018 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage chronic obstructive pulmonary disease 323189 0
palliative care 323190 0
Condition category
Condition code
Respiratory 320772 320772 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 320773 320773 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study participants are recruited from Assisi Hospice Day Care Centre. A routine activity at the Day Care Centre daily is an individualised exercise session. Study participants will have received exercise sessions regardless of their participation in the study. The additional activities imposed by the study and outside of routine care are a 6-minute walk test, a 5-times Sit-to-Stand Test, a St.George's Respiratory questionnaire and collection of physical activity and sitting time data through a physical activity monitor, ActivPal. These tests will take 1 hour at every observation session and performed at recruitment, and 1,3 and 6 months post-recruitment. Assisi Hospice physiotherapist (who is part of the research team) and other research team members will perform these physical tests, questionnaire and ActivPal application on the participants.

The individualised exercises are prescribed and supervised by the physiotherapists and conducted by therapy assistants face-to-face at Assisi Hospice Day Care Centre. These exercise sessions run in tandem with other activities at the day care centre. Participants can attend the day care centre for up to five days based on their attendance at the day care. The exercise session is performed only once daily and the time of exercise is dependent of every patient's day care routine. The duration of each exercise session is between 45-60 minutes with rest breaks in between modalities. Exercise intensity is tailored to each participant’s tolerance at moderate intensity level equivalent to a Borg dyspnoea scale of 3-4/10 and comprise primarily of strengthening and cardiovascular exercises. Exercise prescribed can include pneumatic weights strength training, upper limb, lower limb ergometry or lower limb stepper exercises and group exercises using resistance bands or free weights. The exercises are delivered in a group setting of 4 patients.

Whilst in the study, their participation rate of exercise session at day care center is measured monthly by audit of session attendance. Adverse events will be defined as counts of hospitalisation or death as a result of exercise and severe acute desaturation requiring high level of oxygenation to reverse the hypoxia. Medical follow up with the covering daycare physician will also be arranged if patient is still unwell despite initial measures and falls during exercise.
Intervention code [1] 321422 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328592 0
Time taken to complete 5-times Sit-to-Stand using a stopwatch
Timepoint [1] 328592 0
Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment
Primary outcome [2] 328593 0
1) Distance walked measured by laps around a 25-metre circular track
Timepoint [2] 328593 0
Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment
Primary outcome [3] 328594 0
Quality of life measured by St.George's Respiratory Questionnaire
Timepoint [3] 328594 0
Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment
Secondary outcome [1] 399563 0
Physical activity levels - daily step count measured using ActivPal activity monitor
Timepoint [1] 399563 0
Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment
Secondary outcome [2] 399564 0
Physical activity levels - number of postural changes from sit to stand, measured using ActivPal activity monitor
Timepoint [2] 399564 0
Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment
Secondary outcome [3] 399565 0
Number of adverse events

Composite outcomes: Advers events due to hospitalisations caused by exercise and/or physical tests, or severe acute desaturation requiring high level of oxygenation to reverse the hypoxia, Hospitalisations due to adverse events are measured by the number of admissions from the outpatient daycare centre into inpatient hospice or by accessing patient electronic medical record.
Timepoint [3] 399565 0
Monitored continuously from time of enrolment to 6 months of post-enrolment.
Secondary outcome [4] 399566 0
Participation rate in the exercise program measured by audit of session attendance
Timepoint [4] 399566 0
Monitored monthly from time of enrolment to 6 months post-enrolment
Secondary outcome [5] 407032 0
Physical activity levels - composite measure: time spent in active movements and time spent sitting, measured using ActivPal activity monitor
Timepoint [5] 407032 0
Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment
Secondary outcome [6] 409111 0
Time walked before the first rest, time taken to reach nadir saturation, and time taken for vitals to recover from the Six-minute walk test, using a stopwatch
Timepoint [6] 409111 0
Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment

Eligibility
Key inclusion criteria
1. Stage 3 and 4, Group D patients with chronic obstructive pulmonary disease (COPD)
2. Currently undergoing supervised exercise program in the center
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitively impaired (Abbreviated Mental Test less than 7/10)
2. Orthopedic condition that does not allow exercise testing
3. Any absolute contraindications to exercise testing
4. Cannot comprehend English/Mandarin

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A repeated measures ANOVA (if data is normally distributed) or a Friedman test (if data is non-parametric) will be used to measure changes in STS, 6MWT and SGRQ between multiple time-points (baseline, 1-month, 3-month and 6-month) and changes in sitting time, time spent in active movement and step counts between baseline, 3-month and 6-month timepoints. Pearson’s correlation will be used to measure relationships between outcomes. Level of significance is set at p<0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Surge in Omicron-variant covid cases have limited new referrals into hospice day care. Ethics is due in April 2022 and the recruitment site is not keen to continue as referral of patient population to be studied since September 2021 was zero.
Date of first participant enrolment
Anticipated
Actual
26/07/2021
Date of last participant enrolment
Anticipated
Actual
2/08/2021
Date of last data collection
Anticipated
Actual
22/02/2022
Sample size
Target
10
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 24038 0
Singapore
State/province [1] 24038 0

Funding & Sponsors
Funding source category [1] 309414 0
Self funded/Unfunded
Name [1] 309414 0
NA
Country [1] 309414 0
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Road, S138683
Country
Singapore
Secondary sponsor category [1] 312182 0
None
Name [1] 312182 0
Address [1] 312182 0
Country [1] 312182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309212 0
Agency of Integrated Care (AIC) Institutional Review Board
Ethics committee address [1] 309212 0
5 Maxwell Road, #10-00 Tower Block MND Complex, S069110, Singapore
Ethics committee country [1] 309212 0
Singapore
Date submitted for ethics approval [1] 309212 0
Approval date [1] 309212 0
14/04/2021
Ethics approval number [1] 309212 0
2020-010
Ethics committee name [2] 309217 0
Singapore Institute of Technology (SIT) Institutional Review Board
Ethics committee address [2] 309217 0
10 Dover Road, Singapore 138683
Ethics committee country [2] 309217 0
Singapore
Date submitted for ethics approval [2] 309217 0
Approval date [2] 309217 0
28/04/2021
Ethics approval number [2] 309217 0
2021097

Summary
Brief summary
Patients with end stage pulmonary disease experience a prolonged functional decline associated with a heavy symptom load, emotional distress and social isolation prior to their death. Community palliative care has been evolving to meet the needs of these patients and is a nascent approach in the care spectrum in Singapore. This study aims to understand the impact of a community based supervised exercise programme on the exercise capacity, physical activity levels as well as patient reported quality of life of palliative patients with end stage Chronic Obstructive Pulmonary Disease (COPD) within a 6-month period.

Current Assisi Hospice day care patients who have been diagnosed with Stage 3 or 4, GOLD D COPD and currently undergoing a supervised exercise programme prescribed by a physiotherapist will be recruited into this study.

The 5-time sit to stand (STS) , 6-minute walk test (6MWT) and St George Respiratory Questionnaire (SGRQ) will be measured at the start of the study and at the timepoints of 1 month, 3 months and 6 months to evaluate changes in lower limb muscle strength, exercise capacity and self-reported quality of life for each participant, respectively. The participant’s physical activity levels (PAL) based on their active/sedentary times and number of steps taken per day will also be measured at the start of the study, and then remeasured again at 3 months and 6 months to understand the participant’s activity levels as a result of the supervised exercise programme. PAL are measured by the activity monitor, ActivPal, placed on the front of the right thigh.

As there is a possibility of a floor effect in these patients, other parameters during the 5 time STS and 6MWT will be also be collected. This includes the time walked to first stop/termination of test, time taken to reach nadir saturation, as well as the time required for the patient’s vital signs to recover will also be recorded. Adverse events and participation rate in exercise programmes will also be tracked.

We hypothesise that there is no significant nor clinical important change in 6MWT distance, but significant improvements in time to first rest, time taken to reach nadir saturation and time required for vitals recovery will be observed at 3-month and 6-month timepoints. Significant improvements may be seen in quality of life and sit-to-stand time at 6-month. There will be significant reductions in sitting time at 6-month.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113362 0
A/Prof Rahizan Zainuldin
Address 113362 0
Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683
Country 113362 0
Singapore
Phone 113362 0
+65 65924603
Fax 113362 0
Email 113362 0
[email protected]
Contact person for public queries
Name 113363 0
A/Prof Rahizan Zainuldin
Address 113363 0
Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683
Country 113363 0
Singapore
Phone 113363 0
+65 65924603
Fax 113363 0
Email 113363 0
[email protected]
Contact person for scientific queries
Name 113364 0
A/Prof Rahizan Zainuldin
Address 113364 0
Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683
Country 113364 0
Singapore
Phone 113364 0
+65 65924603
Fax 113364 0
Email 113364 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?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately after publication and ending 3 years after publication.
Available to whom?
Only researchers on a reasonable request and on case-by-case basis by Principal Investigator
Available for what types of analyses?
For IPD meta-analyses and for achieving the aims of the proposal at request
How or where can data be obtained?
Access subject to approval by Principal Investigator, Rahizan Zainuldin through [email protected]


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
No additional documents have been identified.