ANZCTR - Registration

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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 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]

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

palliative care

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Time taken to complete 5-times Sit-to-Stand using a stopwatch

Timepoint [1]

Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment

Primary outcome [2]

1) Distance walked measured by laps around a 25-metre circular track

Timepoint [2]

Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment

Primary outcome [3]

Quality of life measured by St.George's Respiratory Questionnaire

Timepoint [3]

Baseline (0 month) at recruitment, 1 month, 3 month, 6 month post-recruitment

Secondary outcome [1]

Physical activity levels - daily step count measured using ActivPal activity monitor

Timepoint [1]

Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment

Secondary outcome [2]

Physical activity levels - number of postural changes from sit to stand, measured using ActivPal activity monitor

Timepoint [2]

Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment

Secondary outcome [3]

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]

Monitored continuously from time of enrolment to 6 months of post-enrolment.

Secondary outcome [4]

Participation rate in the exercise program measured by audit of session attendance

Timepoint [4]

Monitored monthly from time of enrolment to 6 months post-enrolment

Secondary outcome [5]

Physical activity levels - composite measure: time spent in active movements and time spent sitting, measured using ActivPal activity monitor

Timepoint [5]

Baseline (0 month) at recruitment, 3 month, 6 month post-recruitment

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Singapore

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

Singapore Institute of Technology

Address

10 Dover Road, S138683

Country

Singapore

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Agency of Integrated Care (AIC) Institutional Review Board

Ethics committee address [1]

5 Maxwell Road, #10-00 Tower Block MND Complex, S069110, Singapore

Ethics committee country [1]

Singapore

Date submitted for ethics approval [1]

Approval date [1]

14/04/2021

Ethics approval number [1]

2020-010

Ethics committee name [2]

Singapore Institute of Technology (SIT) Institutional Review Board

Ethics committee address [2]

10 Dover Road, Singapore  138683

Ethics committee country [2]

Singapore

Date submitted for ethics approval [2]

Approval date [2]

28/04/2021

Ethics approval number [2]

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

A/Prof Rahizan Zainuldin

Address

Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683

Country

Singapore

Phone

+65 65924603

Fax

Rahizan.Zainuldin@singaporetech.edu.sg

Contact person for public queries

Name

Rahizan Zainuldin

Address

Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683

Country

Singapore

Phone

+65 65924603

Fax

Rahizan.Zainuldin@singaporetech.edu.sg

Contact person for scientific queries

Name

Rahizan Zainuldin

Address

Health and Social Sciences Cluster
Singapore Institution of Technology
10 Dover Road Singapore 138683

Country

Singapore

Phone

+65 65924603

Fax

Rahizan.Zainuldin@singaporetech.edu.sg

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 Rahizan.Zainuldin@singaporetech.edu.sg

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.

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