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Prehabilitation to Improve outcomes afteR Autologous sTem cEll transplantation (PIRATE) – A randomised controlled trial

Prehabilitation to Improve outcomes afteR Autologous sTem cEll transplantation (PIRATE) – A randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000496910
Acronym
PIRATE
Enrollment
22
Registered
2020-04-20
Start date
2021-04-09
Completion date
2022-08-24
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to see if providing rehabilitation (prehabilitation) before stem cell transplant builds physical strength and fitness. Who is it for? You may be eligible for this study if you are aged 18 of older and are on the waitlist for autologous stem cell transplant. Study details Participants will be randomised by chance (like flipping a coin) into two groups. One group will receive a physiotherapy assessment and standardised exercise advice in addition to standard care. The other group will attend 2 x 60 minute exercise classes per week and receive fortnightly phone calls comprising nutrition education for up to 8 weeks before their transplant. As part of this study, participants will also have a fitness and nutrition assessment, answer questionnaires, provide blood samples and consent to medical records being accessed. It is hoped this research will demonstrate that prehabilitation builds physical strength and fitness, and this will to prevent problems after stem cell transplant, leading to faster recovery from treatment.

Interventions

Name of intervention: Prehabilitation - nutrition education and advice and exercise Who will deliver the intervention: The intervention will be delivered by a physiotherapist and dietitian with experience treating people with cancer. Mode of delivery: exercise - face to face, nutrition face to face and telephone Dose: Participants randomised to the prehabilitation group will be offered a comprehensive physiotherapy assessment and twice weekly, 60-minute exercise classes for up to 8 weeks pre-t

Name of intervention: Prehabilitation - nutrition education and advice and exercise Who will deliver the intervention: The intervention will be delivered by a physiotherapist and dietitian with experience treating people with cancer. Mode of delivery: exercise - face to face, nutrition face to face and telephone Dose: Participants randomised to the prehabilitation group will be offered a comprehensive physiotherapy assessment and twice weekly, 60-minute exercise classes for up to 8 weeks pre-transplant. All participants enrolled in the study will aim to complete 8 weeks of prehabilitation however it is possible they will receive a shorter period of prehabilitation dependent of timing of their stem cell transplant as some patients may not be notified if they are proceeding to transplant until 6 weeks prior. The exercise intervention will be in a circuit format and consist of aerobic and resistance exercise, completed at a moderate intensity (4-6 BORG rating of perceived exertion (RPE) and/or 60-80% Heart rate (HR) maximum for aerobic exercises, 60-80% 1-repetition maximum (for pin-loaded machines or 10-12 repetition maximum (RM) for resistance exercise) in accordance with published guidelines. Exercise will be tailored to each patient following an assessment by the physiotherapist. Participants will complete a 5 minute warm up, aim to complete 25 minutes aerobic exercise, 20 minutes of resistance exercise, 5 minutes of flexibility or balance training (as indicated) and 5 minute cool down. Exercise intensity during aerobic exercise will be monitored by the physiotherapist using the modified BORG scale and using a portable heart rate monitor. During weeks one and two, participants will aim to work at a BORG RPE of 3 (moderate), and by week 8 participants will aim to work at a 5-6 (hard) on the scale. For resistance exercise, weights will be progressed once a participant is achieving 2 to 3 sets of 10-12 repetitions. Resistance exercise may include upper and lower body resistance exercise such as squats, step ups, free weights, wall push-ups, free weights, resistance exercise bands, pin-loaded machines (lat pull down, leg press, chest press). Estimated 1 RM testing will be reassessed at week 4 to ensure sufficient strength training stimulus. Aerobic exercise may include treadmill, stationary cycle, and arm ergometer. Various upper and lower body stretches and balance exercise will also be incorporated into the program as required. Participants in the prehabilitation group will be encouraged to complete an additional 30-minute aerobic exercise training session at home to comply with exercise guidelines for people with cancer. Readily available written instructions with guidelines for exercise after cancer readily available from the American College of Sports Medicine will also be given. Patients will be instructed to remain as active as possible and avoid prolonged periods of sitting and lying in the period following stem cell transplant. Patients will also receive a comprehensive, 60 minute face to face nutrition assessment with a dietitian. The nutrition assessment will comprise review of patients energy intake, food group adequacy and malnutrition screening. The dietitian will provide written information handouts readily available from the Peter Macallum Cancer Centre and fortnightly phone calls including education about weight management, protein intake and dietary balance over the 8 weeks (up to 4 sessions). Location/timing: all exercise and nutrition interventions are completed at home 1:1 with the therapist prior to autologous stem cell transplantation Procedures and Personalisation: Exercise will be tailored to each patient following an assessment by the physiotherapist in accordance with guidelines from the American College of Sports Medicine 2019. Patients will be offered tailored dietary education and advice based on their assessment results with the dietitian.

Sponsors

Eastern Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants recruited from haematology clinics at Eastern Health and affilitated haematology private practices where patients will be referred to Eastern Health for Auto SCT. Participants will be eligible if they: are aged 18 years and over; have a haematological malignancy and are waitlisted for autologous stem cell transplant; and are able to give written informed consent.

Exclusion criteria

Participants will be excluded if patients have a medical condition that contraindicates participation in an exercise-based rehabilitation program as assessed by a physiotherapist or medical practitioner. • They have an Australian-modified Karnofsky Performance status of <60 or ECOG >2. • They have a cognitive impairment that precludes their ability to provide written, informed consent as assessed by their treating clinician.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026