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Feasibility of an Exercise Prehabilitation Program for adults with lymphoma planned to receive Chimeric Antigen Receptor (CAR) T-cell therapy (CAR-T Therapy)

Feasibility of an Exercise Prehabilitation Program for adults with lymphoma planned to receive CAR-T Therapy – The Fit4CAR-T Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000478314
Acronym
The Fit4CAR-T Trial
Enrollment
1
Registered
2026-04-17
Start date
2026-04-08
Completion date
2027-11-30
Last updated
2026-04-27

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

Conditions

None listed

Brief summary

This study is assessing the feasibility of an exercise prehabilitation program for adults with lymphoma planned to receive CAR-T therapy Who is it for? You may be eligible to join this study if you are aged 18 years or above and scheduled to receive CAR-T cell therapy for lymphoma cancer Study details All participants in this study will receive a personalized prehabilitation exercise program with an exercise physiologist involving 3 exercise sessions per week via telehealth for 4 weeks. Each supervised exercise session will go for 30-45 mins and will include aerobic and resistance exercises. Participants will commence exercise sessions up to 4 weeks prior to the planned start of CAR-T therapy and end just before CAR-T therapy commencement. All participants will complete questionnaires and physical assessments at baseline and 2 weeks post-intervention to determine feasibility and efficacy of the program and a questionnaire to assess the acceptability at 2 weeks post-intervention. We hope that the information learned from this study will help to inform larger prehabilitation exercise trials for people with haemotological cancers planned to receive CAR-T therapy.

Interventions

The exercise intervention will consist of an individualised, supervised structured exercise program combining aerobic and resistance exercises delivered through telehealth in the 4 weeks directly prior to starting Chimeric antigen receptor (CAR) T-cell therapy. Exercise Program Participants will be provided with an individualised training program that they will carry out in supervised telehealth sessions at the participant’s home using the telehealth application, Physitrack. This applicatio

The exercise intervention will consist of an individualised, supervised structured exercise program combining aerobic and resistance exercises delivered through telehealth in the 4 weeks directly prior to starting Chimeric antigen receptor (CAR) T-cell therapy. Exercise Program Participants will be provided with an individualised training program that they will carry out in supervised telehealth sessions at the participant’s home using the telehealth application, Physitrack. This application allows for the exercise session to be monitored (including exercise intensity) and instructed online, using mobile devices. The participants will download the application free of charge on their own devices, supported by research staff. The application will not collect any personal information and will only provide the participant with example exercise prescription videos and will be used to monitor participant’s adherence to the study exercise program. Only researchers involved in the study will have access to this exercise adherence information. Participant’s accounts and all information stored in the application will be deleted from the server at the completion of the study as adherence data will be recorded in Research Electronic Data Captue (REDcap) like all other outcome variables. The participants study account will be deleted. Telehealth-based exercise interventions are used routinely, and good adherence has been demonstrated previously by the research team. Any necessary equipment to perform these sessions will be provided for the participants. The exercise physiologist will prescribe and supervise three 30-45 minute sessions of structured exercise per week for 4 weeks. These sessions will include an aerobic (goal 20 minutes per session) and a resistance (goal 10-15 minutes per session) exercise component as well as brief warm-up and cool-down periods (5 minutes each). For the aerobic component, participants will alternate between: Continuous aerobic exercise at a constant intensity (60% maximum capacity or rate of RPE of 12-14) or Interval training (4 x 2 minutes of interval bouts at ~80% of maximal capacity or rate of perceived exertion (RPE) of 16+ separated by 3 minutes of active recovery). Aerobic activities will include step up and on the spot activities, as well as walking outside. The exercise workload corresponding to the required intensity will be individualised for each participant based on their performance in the baseline cardiopulmonary exercise test (CPET). Considering the characteristic undulating health and fatigue status of these patients, participants will be asked to continually rate their RPE throughout the exercise. The RPE scale will provide a measure of the participant’s relative intensity so that we can alter the intensity as necessary. No equipment will be required for this component of the exercise session. The supervised resistance exercise component will comprise simple progressive body-weight and stretch resistance band activities, consisting of 4-6 exercises targeting major muscle groups in the legs, chest, shoulders, arms and core (for example- standing squat, split lunge, chest press, standing row). Participants will be provided with these resistance bands at no cost at the conclusion of the initial testing session. They will not be required to return them at the conclusion of the study. Should they become damaged, study researchers will send them a new one directly at no cost to the participant. Participants will work towards performing 2 sets of each exercise with a goal of 10-12 repetitions at an RPE of 14-16. Once the participants can complete 12 repetitions at an RPE of 13, the intensity will be increased using therabands (stretch resistance bands). Adherence to the exercise prescription will be documented by the physiotherapist or exercise physiologist (who will supervise all sessions), including total exercise duration, RPE and heart rate. Participants will not be offered the exercise intervention following the conclusion of the study.

Sponsors

Baker Heart and Diabetes Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

1) Greater than or equal to 18 years, male or female 2) Scheduled to receive CAR-T cell therapy for lymphoma cancer 3) ECOG Performance status scale of 0-1

Exclusion criteria

1) Any health conditions that are contraindicated to the exercise and testing included in the study 2) Unable to speak or understand English 3) Pregnant or planning to become pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: May 1, 2026