Exercise Guide Trial

Trial Title:

Delivering an individualised web-based exercise intervention (ExerciseGuide) to support men with metastatic prostate cancer: A pilot randomised control trial.

Trial Acronym:

ExerciseGuide

Trial Design:

A pilot two-arm randomised controlled trial examining the acceptability, safety and potential efficacy of ExerciseGuide compared to a wait-list control. Mixed evaluation methods are used, with main outcomes assessed using questionnaires and accelerometers at baseline and post-intervention, and via a qualitative interview at post-intervention only

Collaborators:

The University of Adelaide, The University of Melbourne, Edith Cowan University, Central Queensland University, University of Technology Sydney.  

Trial Coordinator:

Ms Holly Evans

Trial Email:

holly.evans@adelaide.edu.au

Patient Population:

Individuals diagnosed with metastatic prostate cancer not currently experiencing severe bone pain and who have no contraindication to performing moderate exercise (resistance and aerobic) for at least 20 minutes, up to two days of the week. 
Patients should not already be meeting the resistance-training guidelines for cancer survivors (2 sessions per week) and not already completing 60 minutes of structured moderate-vigorous aerobic activity. They can be meeting one of these cut-points but not both. 

Intervention:

The intervention arm will have access to a tailored website, remote supervision, and three tele-coaching sessions to enhance support and adherence. Algorithms will individually prescribe resistance and aerobic exercise based upon factors such as metastasis location, pain, fatigue, confidence, and current exercise levels. Behavioural change strategies and education on exercise benefits, safety and lifestyle are also tailored through the website. The wait-list control arm will be asked to complete usual activities over the eight-week intervention period.

Primary Outcome:

Progression to a definitive trial will be based on performance against the following pre-specified core outcome criteria: 

1. The acceptability of the intervention is satisfactory (score of ≥ 20 on the client satisfaction questionnaire (34).
2. The software usability is satisfactory (score of ≥ 68 on the software usability scale (35); 
3. There are no grade 3+/life threatening or severe adverse events attributed to participating in the intervention using the Common Terminology Criteria for Adverse Events V.5.0 grading criteria. 
4. There is evidence of meaningful participation in either aerobic activity and or resistance-based activity in the intervention group relative to the wait-list control. As the exercise prescription will be personalised, it is difficult to specify an average cut-point, however we anticipate a between-group difference of at least 30 minutes of aerobic activity and/or one session of resistance training.

Secondary Outcomes:

1. Behavioural change mechanisms of action (Self-efficacy; Outcome expectations; Motivation type; Social Support; Intention; Behavioural capability; Habit formation)
2. Health related quality of life (EORTC QLQ-C30; FACIT-Fatigue)
3. Levels of anxiety and depression (HADS)
4. Sleep quality (The Pittsburgh Sleep Quality Index)
5. Physical function (400m self-paced walk; TUG; Repeated chair stand; Repetition maximum)

Status:

Active and recruiting

Sites Recruiting:

AUSTRALIA

Online: www.exerciseguide.org.au

Further Information:

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