Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001283763
Ethics application status
Approved
Date submitted
15/08/2022
Date registered
30/09/2022
Date last updated
7/07/2023
Date data sharing statement initially provided
30/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The EXErcise pRehabilitation Trial (EXERT): A co-design and feasibility study of smartphone delivered exercise prehabilitation in multiple myeloma pre-transplant patients.
Scientific title
The EXErcise pRehabilitation Trial (EXERT): A co-design and feasibility study of smartphone delivered exercise prehabilitation in multiple myeloma pre-transplant patients.
Secondary ID [1] 307819 0
None
Universal Trial Number (UTN)
Trial acronym
EXERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 323532 0
Condition category
Condition code
Cancer 321097 321097 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: Co-design of EXERT app
Eligible participants who have previously completed a face to face prehabilitation program through Barwon Health will be identified by a researcher at the study centre (Barwon Health) and scheduled to attend a focus group workshop. Each workshop will run for approximately 2 hours with a maximum of 5 participants with 2 facilitators. At the workshop, participants will be prompted with a series of questions to discuss the facilitators and barriers to face-to-face prehabilitation. They will also see a presentation of an exercise rehabilitation smartphone app (REMOTE-CR) and be asked to discuss whether they feel it would be beneficial in a prehabilitation setting and what features they would like to enhance the app and target it towards oncology prehabilitation. The focus group will be held online and moderated by a researcher and recoded. Once all participants have been interviewed, their information will be collected and themes identified from the focus group will be provided as feedback to the Deakin University A2I2 team who will then implement the suggestions into the app.
The co-design process will occur during the app development stage and prior to the the commencement of the feasibility study.

Part 2: Feasibility study of EXERT app
A single-arm pre-post-test design will be conducted to determine the feasibility of EXERT for supporting prehabilitation.

The intervention will be delivered individually for 6 weeks, or until clinically indicated, to each participant via their smartphone. During the intervention participants will self-fit a wearable sensor and activate the smartphone app to transmit physiological and geospatial data to the clinician in real-time. Participants will receive real-time coaching, feedback, and support from the clinician delivered as audio notifications via the smartphone app. Participants will be recommended to use earphones to optimise the audio notification user experience, but messages will also be displayed visually in the app. Participants can use the app for self-monitoring of exercise performance during (online) and after (offline) exercise. All participants will complete an in-person 15 minute training session, receive an illustrated user guide, and have access to technical support via email and/or telephone if required. Initial training on how to operate the smartphone app and wearable sensor will be delivered by a researcher when collecting baseline measurements form the participant. Training will include a hands-on demonstration and tutorial lasting approximately 15 minutes, plus an illustrated user guide. These resources have been iteratively designed throughout previous studies of the bespoke telerehabilitation platform and adapted for this study population as required. Participants will choose aerobic exercise modes (e.g. walking, cycling) and locations (e.g. indoor, outdoor) based on personal preferences and access of exercise equipment.

Clinicians will use the web app to monitor participants’ location, distance, speed, heart rate reserve, and self-reported symptoms (if relevant) in real-time throughout exercise. These features will support optimal individualisation and progression of exercise prescription throughout the 6-week prehabilitation period. Clinicians will also use the web app to provide participants with regular coaching instruction, feedback and support in real-time during and after exercise. Coaching interactions will be delivered to participants via the smartphone app as audio alerts, instant/direct messages, push notifications, and/or telephone calls. Participants can be monitored in any environment with an active Wi-Fi or 3G/4G/5G broadband connection, and the platform supports simultaneous monitoring of multiple participants. Barwon Health clinicians will receive comprehensive training to deliver these intervention components. A 2 hour online training workshop will be delivered by an exercise scientist from the investigator team who is experiences using the telerehabilitation platform. Clinician training will be delivered two weeks prior to the commencement of study recruitment. Ongoing support will be provided as required.

Physiotherapists will prescribe individualised exercise programs based on clinical characteristics, baseline assessments, and observed exercise tolerance (including impact of exercise on symptoms and/or effects of concomitant cancer therapies). Maximum training frequency, duration, and intensity level are anticipated to be 5 x 60 minutes per week at a perceived exertion of up to 15 (‘hard’) on the RPE scale, but may be extended to meet individual needs based on clinical judgment. Prescriptions will be communicated to participants via the EXERT app at the beginning of each exercise training session. All exercise training sessions will include warm up and cool down phases to enable appropriate cardiovascular and musculoskeletal preparation and recovery.

In addition to the aerobic exercise being monitored by the sensor, participants will also complete regular resistance training using the Physitrack exercise prescription platform, which is already being used by Physiotherapy and Exercise Physiology staff at Barwon Health and has been approved by Barwon Health IT services. Participants will use mobile apps to receive individualised resistance training programs prescribed by physiotherapists. Programs will indicate target exercise volumes and intensity levels, and video demonstrations of correct exercise technique. Participants are anticipated to complete resistance training exercise individually but will not be prevented from exercising with others (whether participating in the study or not) if they choose. Resistance training exercises will target all major muscle groups (e.g., upper and lower body; push, pull, bend, and twist). Specific prescriptions will be individualised in a similar manner to aerobic training (see above). Clinicians will utilise the tracking function within the app to capture how often participants interact/complete the exercises within the app.
Intervention code [1] 321651 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328878 0
Walk distance during a six-minute walk test (6MWT)
Timepoint [1] 328878 0
Baseline and 6 weeks after intervention commencement
Primary outcome [2] 328879 0
30 second sit-to-stand (STS) score
Timepoint [2] 328879 0
Baseline and 6 weeks after intervention commencement
Primary outcome [3] 332418 0
Two-minute step test
Timepoint [3] 332418 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [1] 400755 0
Health related quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Timepoint [1] 400755 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [2] 400756 0
Physical activity using the Godin Leisure Time Physical Activity (GLTPA) questionnaire
Timepoint [2] 400756 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [3] 413435 0
Exercise intervention adherence (number of sessions completed/number of sessions prescribed). Prescribed vs Completed sessions will be tracked by clinicians during exercise monitoring, The EXERT app and Physitrack also log data when completing sessions within the app which will be used to cross-check completed sessions against clinician logs.
Timepoint [3] 413435 0
6 week post baseline
Secondary outcome [4] 413440 0
Self-reported changes in health status will be collected during follow-up assessment using a questionnaire designed specifically for the study. Physiotherapists’ clinical judgement will determine the need to follow-up any symptoms reported by participants via the EXERT app during exercise, and adverse events arising from such follow-up will be document as required.
Timepoint [4] 413440 0
6 week post baseline
Secondary outcome [5] 413441 0
A participant exit survey on user acceptability and experience (process evaluation) designed specifically for the study
Timepoint [5] 413441 0
6 weeks post baseline

Eligibility
Key inclusion criteria
Eligible participants will be aged 18+ years; have multiple myeloma (primary diagnosis) and be approaching a stem cell transplant, and can understand and write English as the application is currently only available in english. Medical clearance to participate in exercise will be implied by the referral from their treating team. Participants will need to have access to a smart phone (Android or iOS) and up to 500MB per month of data to operate the app.
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 multiple myeloma is not their primary diagnosis and stem cell transplant is not in their course of treatment; if they have neurological compromise due to pathological spinal fractures, or evidence of cognitive impairment or medical instability that would indicate that remotely supervised exercise may not be safe, as deemed by the health-care professional conducting the assessment (Barwon Health).

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
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
Based on referral numbers from Barwon Health’s Face to Face prehabilitation pilot program, we aim to recruit a minimum of 9 multiple myeloma transplant patients over the course of 6 months. The sample size is limited due to study timeframe and current referral rates of multiple myeloma into the Barwon health Oncology Prehabilitation program.

Participant characteristics and outcome data will be summarised descriptively for the full sample. A linear regression model—adjusted for baseline values—will be fitted to assess changes in 6MWT and other outcomes.

Interviews will be recorded, transcribed, and entered into NVivo. An inductive analysis approach will be used to identify the key themes that emerge from the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20495 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 35267 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 309627 0
University
Name [1] 309627 0
Deakin University Institute for Physical Activity and Nutrition (IPAN)
Country [1] 309627 0
Australia
Primary sponsor type
University
Name
Deakin University Institute for Physical Activity and Nutrition (IPAN)
Address
221 Burwood Highway, Burwood
VIC 3125
Country
Australia
Secondary sponsor category [1] 310646 0
Hospital
Name [1] 310646 0
Barwon Health
Address [1] 310646 0
PO Box 281
Geelong VIC 3220
Country [1] 310646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309402 0
Barwon Health Research Ethics Governance and Integrity Unit
Ethics committee address [1] 309402 0
PO Box 281
Geelong VIC 3220
Ethics committee country [1] 309402 0
Australia
Date submitted for ethics approval [1] 309402 0
Approval date [1] 309402 0
15/09/2021
Ethics approval number [1] 309402 0

Summary
Brief summary
Prehabilitation prior to stem cell transplant surgery for patients with multiple myeloma may enhance their recovery after the transplant, but delivery of these sessions in person may not be achievable for a variety of reasons. This study aims to modify an existing telehealth exercise platform (REMOTE-CR) to ensure that it is useful for patients with multiple myeloma. The revised platform will then be tested in a new exercise app (EXERT) to determine whether it is feasible for prehabilitation to be delivered via telehealth in this manner.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have a primary diagnosis of multiple myeloma, you are scheduled to receive a stem cell transplant, and you can understand and write English.

Study details
All participants who choose to enrol in this study will be given instructions on how to download and use the EXERT app to complete their prehabilitation program. After enrolment, all participants will be reviewed by a physiotherapist to determine their current fitness and fatigue levels. The physiotherapist will then design an exercise program for each participant based on their requirements and this program will be delivered through the EXERT app over a 6 week period. Over the study period participants will be asked to wear a sensor (similar to a Fitbit) that will record their heart rate, distance and speed of exercises performed. These details will be reviewed by the study clinicians who can then tailor the exercise program for participants to ensure that they aren't over-or under-exerting themselves.

It is hoped that the EXERT app will be well received by those who are unable to attend face –to-face oncology rehabilitation at Barwon Health, and that this method of prehabilitation delivery will be shown to be feasible and acceptable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114030 0
Prof Ralph Maddison
Address 114030 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 114030 0
Australia
Phone 114030 0
+61 03 924 46218
Fax 114030 0
Email 114030 0
ralph.maddison@deakin.edu.au
Contact person for public queries
Name 114031 0
Prof Ralph Maddison
Address 114031 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 114031 0
Australia
Phone 114031 0
+61 03 924 46218
Fax 114031 0
Email 114031 0
ralph.maddison@deakin.edu.au
Contact person for scientific queries
Name 114032 0
Prof Ralph Maddison
Address 114032 0
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 114032 0
Australia
Phone 114032 0
+61 03 924 46218
Fax 114032 0
Email 114032 0
ralph.maddison@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.