ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

EXERT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple Myeloma

Condition category

Condition code

Cancer

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Walk distance during a six-minute walk test (6MWT)

Timepoint [1]