Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000289617
Ethics application status
Approved
Date submitted
22/11/2022
Date registered
17/03/2023
Date last updated
17/03/2023
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty in people with chronic respiratory conditions referred to Pulmonary Rehabilitation: A pilot study
Scientific title
Frailty in people with chronic respiratory conditions referred to Pulmonary Rehabilitation: A pilot study
Secondary ID [1] 308467 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory disease 328872 0
Condition category
Condition code
Respiratory 325322 325322 0 0
Chronic obstructive pulmonary disease
Respiratory 325323 325323 0 0
Asthma
Respiratory 325324 325324 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a pulmonary rehabilitation program of exercises twice a week for eight weeks, groups of 1:6 ration - staff to participant ratio, supervised by experienced pulmonary rehabilitation physiotherapists (i.e., 16 sessions). Participants will be invited to attend the exercise sessions face-to-face, however, with adaptations put in place during the global pandemic, participants will be given the option to attend exercise session supervised by experienced pulmonary rehabilitation physiotherapists virtually via zoom. The exercise program will include upper limb and lower limb endurance training, strength training and balance exercises. Exercise sessions will be between 40 to 60 minutes including rest periods. Participants will perform upper limb endurance exercises using either an arm ergometer or light weights with high repetitions; lower limb endurance training using either a cycle ergometer, treadmill, ground walking or marching on the spot; strength training for upper limbs using fixed weight machines or hand weights or resistance bands and for lower limb using fixed weight machines or body weight exercises (e.g. squats, sit-to-stand, step-ups). Session attendance checklist will be completed by the physiotherapist. During endurance exercise sessions participants will be asked to exercise at an intensity that elicits a breathlessness or fatigue score of 3 (moderate) to 4 (somewhat severe) on the 0-10 category ratio scale (Borg 1998). For weight training, Rate of Perceived Exertion (RPE) scale will be aimed between 15 (Vigorous/Very Hard) to 18 (Very heavy, can perform no more than 10 repetitions).
Before commencing exercise, participants will be asked to inform the supervising physiotherapist if they have any change in how they feel or any new symptoms. Participants will be advised to stop exercise if they have any concerns.
A pulmonary rehabilitation physiotherapist will discuss with you the needs on lung disease specific education sessions at the initial assessment. Education sessions will be referred to the “Better Living with Chronic Obstructive Pulmonary Diseases” Lung Foundation Australia online resources Better living with Chronic Obstructive Pulmonary Diseases - Lung Foundation Australia. The online resources contain short videos and written resources that participant can print off. Education topics include strategies to manage breathlessness; importance of physical activity and exercise; medications and inhaler techniques; healthy eating; managing daily activities; managing anxiety and depression. If any of the topics is required after their discussion with the pulmonary rehabilitation physiotherapist, the physiotherapist will ask the participant to attend the pulmonary rehabilitation exercise program 15 minutes prior or after the exercise session starts or finish respectively to go through the topic that is required. Participants will be asked by the physiotherapist to book in a one-on-one session with the physiotherapist if any topic is required to be discussed privately.
Intervention code [1] 324911 0
Rehabilitation
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333183 0
physical frailty will be assessed using Short Physical Performance Battery tool.
Timepoint [1] 333183 0
At initial assessment and final assessment (8 to 9 weeks after intervention commencement).
Primary outcome [2] 333364 0
Anxiety assessed by Hospital Anxiety and Depression scale anxiety component
Timepoint [2] 333364 0
At initial assessment and final assessment (8 to 9 weeks after intervention commencement).
Primary outcome [3] 333365 0
Depression assessed by Hospital Anxiety and Depression Scale depression component
Timepoint [3] 333365 0
At initial assessment and final assessment (8 to 9 weeks after intervention commencement).
Secondary outcome [1] 416083 0
To determine the proportion of people with chronic respiratory diseases referred to pulmonary rehabilitation who have physical frailty, anxiety and/or depression. Numbers of people with chronic respiratory diseases referred to pulmonary rehabilitation will be presented in numerical numbers as denominator. Numbers of these people who have physical frailty, anxiety and/or depression will also be recorded in numerical numbers as numerator. These numbers will be recorded in the Sydney Local Health District REDCap secure software system and percentage will be calculated in this system.
Timepoint [1] 416083 0
At final assessment (8 to 9 weeks after intervention commencement).
Secondary outcome [2] 418899 0
To understand the barriers and facilitators to uptake, attendance and completion of pulmonary rehabilitation in people who are frail, anxious or depressed in order to develop strategies to improve outcomes. Semi-structured one-to-one interviews will be conducted and will be audio/video recorded, transcribed verbatim and interviews will be coded and analysed for key themes, Results will be recorded in the Sydney Local Health District REDCap system. The semi-structured interview will explore reasons for not commencing a Pulmonary Rehabilitation program. Number of participants interviewed will depend on reaching saturation of themes.
Timepoint [2] 418899 0
At final assessment.

Eligibility
Key inclusion criteria
• People diagnosed with chronic respiratory disease/s including Chronic Obstructive Pulmonary Disease, chronic asthma, Interstitial lung disease, bronchiectasis, lung cancer, referred to a pulmonary rehabilitation program in Sydney Local Health District.
• Age range greater and equal to 40 years old
• Sex: All genders
• Willing to provide informed consent and willing to participate and comply with the study requirements.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People with acute symptoms of any illness where exercise is not recommended
• People who have difficulty understanding English or are unable to have access to an interpreter
• People with severe cognitive impairment or other comorbidities which would make exercise unsafe

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total of 90 participants will be required. The sample size is based on the second aim i.e., to determine the effect of independent variables of physical frailty (SPPB score), anxiety (anxiety score from the HADS) and depression (depression score from HADS) on number of PR sessions attended. As there are three independent variables, we have calculated that 90 participants will be required, since 50 participants are required for one variable in a multiple regression analysis and 20 participants for each additional variable. We estimate that two years will be needed for recruitment as currently 30 people with chronic respiratory diseases per month are referred to the PR programs in SLHD. As PR is provided for 11 months per year, there are approximately total of 330 eligible patients per year. Based on previous studies in PR in SLHD, it is feasible to recruit 90 participants within two years since, we expect at least 75% of those referred to PR to be eligible (i.e., 495 patients over 2 years) and 50% of these (i.e. 247) could potentially to consent to the study.

Multiple regression as an extension of simple linear regression will be analysed using SPSS statistics software. To quantify the correlation between two variables, Pearson correlation coefficient which is a measure of the linear association between two variables (i.e. physical frailty score and anxiety score or physical frailty score and depression score).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
7/04/2025
Actual
Date of last data collection
Anticipated
9/06/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23628 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23629 0
Balmain Hospital - Balmain
Recruitment hospital [3] 23630 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 23719 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 39157 0
2031 - Randwick
Recruitment postcode(s) [2] 39049 0
2041 - Balmain
Recruitment postcode(s) [3] 39048 0
2050 - Camperdown
Recruitment postcode(s) [4] 39050 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 312709 0
Government body
Name [1] 312709 0
Sydney Local Health District
Country [1] 312709 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Pulmonary Rehabilitation, Physiotherapy Department, QE II Rehabilitation Centre, 57-59 Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 314516 0
None
Name [1] 314516 0
none
Address [1] 314516 0
none
Country [1] 314516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312010 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 312010 0
Research Ethics & Governance Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 312010 0
Australia
Date submitted for ethics approval [1] 312010 0
06/01/2023
Approval date [1] 312010 0
06/02/2023
Ethics approval number [1] 312010 0

Summary
Brief summary
Pulmonary rehabilitation (PR) is effective in reducing exacerbations and hospital admissions, improving health-related quality of life, exercise tolerance, and symptoms of breathlessness and fatigue in people with chronic obstructive pulmonary disease (COPD) and other chronic lung diseases such as interstitial lung disease, Bronchiectasis. However, despite the robust evidence for the benefits of PR, uptake is low, with 8-50% of those referred to PR never attend and 10-32% of those who commence not completing the program. Studies from the United Kingdom report that low PR program uptake, high non-attendance and non-completion rate are particularly evident in people who have physical frailty or high levels of anxiety and/or depression.
In the elderly population with chronic lung disease, frailty is characterised by multisystem decline encompassing physical, cognitive, social and psychological aspects. Frailty is prevalent in people with COPD when compared to healthy age-matched community living individuals as young as 50 years old and is strongly associated with a higher risk of mortality. One in five people who are frail and living with COPD suffer from adverse outcomes such as increased risk of acute exacerbations and hospitalisations. A recent systematic review reported that frailty is associated with respiratory impairment and poorer health-related quality of life in people with COPD, idiopathic pulmonary fibrosis (IPF) (a subcategory of ILD) and asthma. There are no studies in people with other chronic lung diseases, such as ILD other than IPF or bronchiectasis, who are commonly referred to PR. Thus, frailty is now highlighted as an important condition that needs to be recognised and managed to improve patient outcomes and reduce healthcare costs. However, in Australia, there are no data on the proportion of people with chronic respiratory diseases referred to PR who have physical frailty, anxiety and/or depression, and the relationship between physical frailty, anxiety and/or depression and the uptake, attendance and completion of PR in people with chronic lung disease is unknown. The hypothesis of the study is people who have chronic lung disease and is physically frail, anxious and/or depressed have poor uptake, attendance and completion of a PR program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123162 0
Dr Ling-Ling Tsai
Address 123162 0
Pulmonary Rehabilitation, Physiotherapy Department, QEII Rehabilitation Centre, 57-59 Missenden Road Camperdown, NSW, 2050
Country 123162 0
Australia
Phone 123162 0
+61 2 95159857
Fax 123162 0
Email 123162 0
lingling.tsai@health.nsw.gov.au
Contact person for public queries
Name 123163 0
Dr Ling-Ling Tsai
Address 123163 0
Pulmonary Rehabilitation, Physiotherapy Department, QEII Rehabilitation Centre, 57-59 Missenden Road Camperdown, NSW, 2050
Country 123163 0
Australia
Phone 123163 0
+61 2 95159857
Fax 123163 0
Email 123163 0
lingling.tsai@health.nsw.gov.au
Contact person for scientific queries
Name 123164 0
Dr Ling-Ling Tsai
Address 123164 0
Pulmonary Rehabilitation, Physiotherapy Department, QEII Rehabilitation Centre, 57-59 Missenden Road Camperdown, NSW, 2050
Country 123164 0
Australia
Phone 123164 0
+61 2 95159857
Fax 123164 0
Email 123164 0
lingling.tsai@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will only be available for the listed investigators in the protocol that has been approved by the ethics committee.


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.