Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000550404
Ethics application status
Approved
Date submitted
13/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based exercise using remote supervision for adults with chronic respiratory disease
Scientific title
Home-based Minimal Equipment Exercise Training (H-MEET) delivered using remote supervision: A randomised controlled feasibility study in adults with chronic respiratory disease
Secondary ID [1] 314354 0
Nil known
Universal Trial Number (UTN)
Trial acronym
H-MEET RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory disease 337336 0
Condition category
Condition code
Respiratory 333724 333724 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 333725 333725 0 0
Other physical medicine / rehabilitation
Respiratory 333727 333727 0 0
Other respiratory disorders / diseases
Respiratory 333726 333726 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess whether a remotely supervised home-based minimal equipment exercise training program is a feasible and acceptable model of pulmonary rehabilitation for people with chronic respiratory disease.

Home-based minimal equipment exercise training program involves twice-weekly sessions for 8 weeks, in groups of 2-4 participants at a time. The sessions are remotely supervised by an experienced exercise physiologist or physiotherapist (via video-conferencing), participants will be able to interact via video-conferencing technology with other group participants and the supervising clinician. Each session, participants will undertake circuit-based training incorporating 7 exercises. Exercises included in the program are sit to stand, air boxing, step up, step to side with lateral raise, bent over row. The total training session duration will be 45minutes; each exercise circuit will be between 15-16minutes in duration (including interval rests) and repeated 3 times, accounting for a total exercise time of 31.5minutes. A 5minute rest period will be undertaken between each circuit.

Intensity
Moderate-intensity exercise training will be prescribed and progressed according to guidelines, Borg dyspnoea score 3-4 correlating to the equivalent of work rate greater than or equal to 60% VO2peak (Mellerick et al. unpublished). Exercise will be progressed each week to ensure time and load correlate to Borg dyspnoea scores of 3-4 (Gloeckl R et al. Eur Resp Rev, 2013). If unable to progress time due to fatigue or endurance issues, load may be progressed first.

Participants ratings of perceived exertion and breathlessness, heart rate and oxygen saturation will be monitored throughout the sessions. Heart rate and oxygen saturation will be measured via an ear probe pulse oximeter worn in a Nonin oximeter bag with cross body strap.
All equipment required to undertake the tele-rehabilitation will be supplied by the study investigators for the duration of the rehabilitation period.

Home Visit
An initial home visit will be completed by an experienced clinician prior to program commencement. The home visit will involve delivery of the intervention kit including equipment and iPad, setting up the exercise circuit and a familiarisation session to ensure appropriate exercise and videoconferencing set-up. The participant will be provided with a participant exercise booklet and instruction manual to assist with videoconferencing set-up and troubleshooting issues. To ensure the safety of the healthcare professional during home visits, the relevant institution Home Visit Assessment Policy will be adhered to as per standard practice. We have previously completed trials involving these processes in delivering telerehabilitation with no risk or harm to participants or clinicians.
Intervention code [1] 330970 0
Treatment: Other
Comparator / control treatment
The control group will receive traditional outpatient centre-based pulmonary rehabilitation program. Traditional outpatient centre-based pulmonary rehabilitation utilises specialised equipment such as treadmills, cycle ergometers and specialised resistance equipment. This involves twice-weekly exercise training sessions for 8 weeks, in directly supervised groups of 8-12 participants. Program is delivered by an experienced exercise physiologist or physiotherapist. Each session, participants will undertake continuous aerobic exercise for a total of 30minutes on a cycle ergometer or treadmill and complete upper and lower limb resistance training. Aerobic training will be individually prescribed and progressed according to a standardised protocol utilising Borg dyspnoea scores 3-4 (Gloeckl R et al. Eur Resp Rev, 2013). For resistance training, this will comprise of both upper and lower limb strength training exercises including exercises such as; sit to stand, upright row, step up.
Exercise will be progressed each week to ensure intensity correlates to Borg dyspnoea scores of 3-4 (Gloeckl R et al. Eur Resp Rev, 2013), (Cox NS et al. Thorax, 2022).
Control group
Active

Outcomes
Primary outcome [1] 341343 0
Acceptability (intervention group only)
Assessment method [1] 341343 0
Telehealth satisfaction survey (TeSS) - a 10-item questionnaire to assess patient satisfaction with telehealth. Qualitative interviews - undertaken to explore and understand participant perceptions and experiences of the H-MEET program. The purpose of conducting these qualitative interviews is to explore objectives of personal views, barriers and facilitators, explore contextual factors, program design and explain reasons of acceptance or rejection of the program.
Timepoint [1] 341343 0
At end of 8-week intervention
Primary outcome [2] 341318 0
Feasibility
Assessment method [2] 341318 0
Recruitment of >25% of eligible candidates - audit of recruitment records
Timepoint [2] 341318 0
At study completion
Primary outcome [3] 341319 0
Feasibility
Assessment method [3] 341319 0
Program completion by >60% of randomised participants as defined by attendance at a pre-defined threshold of 70% [>11] of scheduled sessions - audit of study attendance records
Timepoint [3] 341319 0
At study completion
Secondary outcome [1] 447106 0
Change in breathlessness scores
Assessment method [1] 447106 0
modified Medical Research Council dyspnoea scale (mMRC) - change in mMRC scores from baseline to end intervention
Timepoint [1] 447106 0
Baseline, end of 8-week intervention
Secondary outcome [2] 447104 0
Change in Health-related Quality of life
Assessment method [2] 447104 0
Chronic Respiratory Disease Questionnaire - change in dyspnoea; fatigue; emotional function; and mastery (CRQ-D, F, E, M) domain scores from baseline to end of 8-week intervention
Timepoint [2] 447104 0
Baseline, end of 8-week intervention
Secondary outcome [3] 447107 0
Change in exercise capacity
Assessment method [3] 447107 0
6-min walk test (6MWT) - change in distance walked on 6MWT (6MWD) from baseline to end intervention
Timepoint [3] 447107 0
Baseline, end of 8-week intervention
Secondary outcome [4] 447105 0
Change in psychological wellbeing
Assessment method [4] 447105 0
Hospital Anxiety and Depression Scale (HADS) - change in HADS scores from baseline to end intervention
Timepoint [4] 447105 0
Baseline, end of 8-week intervention

Eligibility
Key inclusion criteria
This study will include people aged 18 years and over with a confirmed diagnosis of chronic respiratory disease who are referred to pulmonary rehabilitation at Alfred Health, VIC, Melbourne.
As the intervention will be delivered in English and remotely via video-conferencing, participants must be able to read and communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded from this study if they have:
• Co-morbidities which preclude exercise training e.g. unstable angina, neuromuscular condition
• Myocardial event within the previous 6 weeks
• Unstable asthma with a hospital admission or emergency department presentation within the last 3 months
• History of syncope on exertion
• Significant cognitive impairment
• Respiratory admission to acute care within the previous 30 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to intervention or control using online (computerised) sequence generation software undertaken by a researcher independent of the study team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was estimated to evaluate the primary outcomes of feasibility and acceptability of the exercise intervention, based on guidance from previous literature (Paixao C et al. Heart Lung. 2023), (Lewis A et al. BMJ Open Respir Res. 2021), (Cox NS et al. Respir Care. 2015), (Khor YH et al. Sci Rep. 2021), (Eldridge SM et al. CONSORT. 2016)

No formal power calculation is required as this is a feasibility trial. We will aim to recruit a total of 30 participants, as this will be sufficient to capture a representative range of age, diagnosis and comorbidities. The trial will not be powered to identify change in the secondary outcomes; however, outcome data may be used to inform sample size calculation for a larger trial.

Descriptive statistics will be employed for quantitative data, using n (%) for categorical data and mean (SD) or median (interquartile range) depending on distribution for continuous data. Between-group differences will be assessed using chi2 test for categorical data and 2-sided tests (parametric or non-parametric depending on data distribution) will be used for continuous data (a<0.05).

Qualitative data - interview transcripts
All de-identified transcripts of the interviews will be analysed by two researchers independently. Descriptive codes will be generated to represent the data. Related codes will be collapsed into defining subthemes, ideas or categories. Data will then be identified into broader themes and categories for interpretation and linking back to the research questions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
28/05/2027
Actual
Date of last data collection
Anticipated
2/08/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27876 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 44072 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318874 0
University
Name [1] 318874 0
Monash University
Country [1] 318874 0
Australia
Primary sponsor type
University
Name
Monash University
Country
Australia
Secondary sponsor category [1] 321335 0
None
Name [1] 321335 0
Country [1] 321335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317487 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317487 0
Ethics committee country [1] 317487 0
Australia
Date submitted for ethics approval [1] 317487 0
14/11/2024
Approval date [1] 317487 0
04/02/2025
Ethics approval number [1] 317487 0
113519 (Local Reference: Project 744/24)

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 141210 0
Prof Anne Holland
Address 141210 0
Level 6, The Alfred Centre, Respiratory Research@Alfred, School of Translational Medicine, 99 Commercial Road, Melbourne VIC 3004
Country 141210 0
Australia
Phone 141210 0
+61 99030214
Email 141210 0
anne.holland@monash.edu
Contact person for public queries
Name 141211 0
Christie Mellerick
Address 141211 0
Level 6, The Alfred Centre, Respiratory Research@Alfred, School of Translational Medicine, 99 Commercial Road, Melbourne VIC 3004
Country 141211 0
Australia
Phone 141211 0
+61 399038945
Email 141211 0
christie.mellerick@monash.edu
Contact person for scientific queries
Name 141212 0
Christie Mellerick
Address 141212 0
Level 6, The Alfred Centre, Respiratory Research@Alfred, School of Translational Medicine, 99 Commercial Road, Melbourne VIC 3004
Country 141212 0
Australia
Phone 141212 0
+61 03 99038945
Email 141212 0
christie.mellerick@monash.edu

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be available on a case by case basis, at the discretion of the Co-ordinating Principal Investigator and the relevant Human Research Ethics Committee.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Type of analysis data will be available for will be at the discretion of the relevant Human Research Ethics Committee.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Access to data will be subject to approval by the Co-ordinating Principal Investigator and approval by the relevant Human Research Ethics Committee.
Co-ordinating Principal Investigator: Prof Anne Holland, anne.holland@monash.edu

Are there extra considerations when requesting access to individual participant data?
No


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.