Exercise Intervention for Blood Cancer Patients Post-Transplant

Overseen By Kelly Clohesey Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Inability to walk unassisted

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a wearable device and smartphone app can aid blood cancer patients in recovering more effectively after a bone marrow transplant. The device prompts patients to engage in short exercise sessions while hospitalized. The goal is to determine if these reminders can enhance physical recovery and overall well-being. It suits individuals diagnosed with blood cancer who are undergoing a bone marrow transplant and can walk unassisted for 15 minutes. Participants will wear the devices and receive exercise cues during part of their hospital stay. As an unphased trial, this study provides patients an opportunity to contribute to innovative recovery methods that could improve future care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor.

What prior data suggests that this exercise intervention using wearable devices and a smartphone app is safe for blood cancer patients post-transplant?

Research shows that wearable devices used to encourage exercise are generally safe and well-tolerated. Previous studies have demonstrated that these devices assist individuals, such as stroke survivors, by reminding them to move. These reminders, often delivered as gentle vibrations, motivate regular exercise without causing harm.

While specific data for blood cancer patients is not yet available, the wearable technology resembles fitness trackers like Fitbits, which are usually safe for everyday use. The goal is to promote gentle exercise, typically low-risk, to support recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for blood cancer patients post-transplant focus on medical and pharmaceutical interventions to support recovery and prevent complications. However, this new approach uses wearable devices and a custom smartphone application to encourage regular exercise, which is a unique method for enhancing patient recovery. The treatment is exciting because it combines technology with physical activity, aiming to improve patient outcomes by promoting movement and potentially speeding up recovery. The use of wearable devices to deliver real-time exercise cues is a novel approach that could make exercise more accessible and engaging for patients during their hospital stay. Researchers are enthusiastic about this innovative blend of technology and exercise because it represents a shift toward holistic and personalized patient care.

What evidence suggests that this exercise intervention using wearable devices and a smartphone app is effective for blood cancer patients post-transplant?

Research has shown that wearable devices and smartphone apps that remind people to exercise can enhance recovery and well-being in patients. In this trial, participants will receive exercise reminders through cues from wearable devices and a custom smartphone application. Studies have found that these tools can encourage cancer patients to remain active, which is crucial for their recovery. For example, fitness trackers monitor physical activity, heart rate, and calories burned during cancer treatment. These devices send reminders to move, promoting regular exercise. This method aims to simplify staying active, aiding recovery after a bone marrow transplant. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with blood cancers who are about to have a bone marrow transplant. They need their doctor's okay to join and must be able to walk for 15 minutes without help.

Inclusion Criteria

I am scheduled for a bone marrow transplant from a donor.

I have been diagnosed with a blood cancer.

Physician consent to participate in the study

Exclusion Criteria

I cannot walk for 15 minutes without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-transplant Inpatient Stay

Participants use wearable devices and a smartphone app to receive exercise cues during their inpatient stay

Approximately 30 days

Continuous monitoring during hospital stay

Cued Exercise Intervention

Participants receive cues to exercise on days 3-10 post-transplant, with three scheduled exercise sessions per day

7 days

Monitoring without Intervention

Participants wear devices without receiving exercise cues on days 1-2 and from day 11 until discharge

Approximately 21 days

Follow-up

Participants are monitored for feedback and efficacy of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cued Exercise Using Wearable Devices and a Custom Smartphone Application

Trial Overview The study tests if using wearable devices like a Fitbit, along with a custom smartphone app that reminds patients to move, helps recovery during the hospital stay after a bone marrow transplant.

How Is the Trial Designed?

Group I: Reminders to exercise through cues provided by wearable device + custom smartphone application Experimental Treatment 1 Intervention

Each participant receives 2 wearable devices and custom smartphone application. Participants will wear an activity monitor on their non-dominant wrist and contralateral ankle. Post-transplant inpatient days \~3-10, participants will schedule three cued exercise sessions each day using the smartphone application. At the scheduled time, the wearable devices will vibrate to indicate "time to exercise" and participants are encouraged to complete an exercise task for 15 minutes. Post-transplant inpatient hospital days \~1-2 and post-transplant inpatient hospital days \~11 until discharge patients will wear the devices but will not receive any cues. During these days, the monitors will only be measuring their movement without any intervention.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study of 61 allogeneic stem cell transplant patients, both therapist-supervised and patient-directed exercise programs led to significant improvements in physical performance, with the supervised group showing slightly better results in walking distances after 4 weeks of training.

Both groups experienced a reduction in fatigue levels, although this change was not statistically significant, indicating that exercise can be beneficial for functional outcomes in transplant patients regardless of supervision style.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Shelton, ML., Lee, JQ., Morris, GS., et al.[2009]

A systematic review of 8 studies found that exercise interventions significantly improve cardiorespiratory fitness and lower extremity muscle strength in patients with hematologic malignancies undergoing stem cell transplantation, with effect sizes of 0.53 and 0.56, respectively.

Exercise also helps reduce fatigue and positively impacts overall quality of life, although all studies had some risk of bias, indicating a need for further high-quality research to confirm these benefits and optimize exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. Persoon, S., Kersten, MJ., van der Weiden, K., et al.[2022]

Hematopoietic stem cell transplant (HSCT) can be a curative treatment for blood cancers, but it often leads to decreased quality of life and performance status in patients.

The use of wearable technologies may help overcome barriers to exercise, making it easier for HSCT patients to participate in exercise therapy, which has been shown to improve their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. Pottebaum, E., Warmoth, A., Ayyappan, S., et al.[2023]

The GO-EXCAP intervention, which combines a mobile app with a home-based exercise program, was found to be feasible and usable for older patients (average age 72) with myeloid neoplasms undergoing outpatient chemotherapy, with an 88% retention rate and 82% of patients logging exercise data.

Patients increased their average daily steps from 2848 to 3184 and engaged in resistance exercises for about 26.2 minutes per day, indicating that the program effectively encouraged physical activity despite the challenges older patients face in adhering to exercise regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Loh, KP., Sanapala, C., Watson, EE., et al.[2022]

A feasibility randomized controlled trial involving patients undergoing allogeneic hematological stem cell transplant (allo-HSCT) showed that an exercise program delivered before, during, and after the transplant was safe, with no adverse events linked to the exercise intervention.

Participants in the exercise group improved their six-minute walk test distances by an average of 45 meters before the transplant, suggesting that exercise may enhance physical function in this patient population and warrants further research with larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. Santa Mina, D., Dolan, LB., Lipton, JH., et al.[2020]

A pilot study involving 17 adult hematopoietic stem cell transplant (HSCT) recipients showed that a home-based aerobic exercise program was safe and led to significant improvements in aerobic fitness, fatigue severity, and physical well-being over 12 weeks.

No exercise-related adverse events were reported, indicating that this individualized exercise approach is an acceptable and potentially effective intervention for enhancing physical functioning in sedentary HSCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. Wilson, RW., Jacobsen, PB., Fields, KK.[2022]

A structured exercise program implemented four weeks before allogeneic hematopoietic stem cell transplantation (allo-HSCT) significantly helps reduce fatigue and prepares patients physically and mentally for the procedure, based on a study of 67 adult patients.

The study highlights the importance of individualized support and motivation to maintain exercise routines, as fatigue levels varied among different patient sub-groups throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Feasible Exercise Programme in an Allogeneic Haematopoietic Stem Cell Transplantation Setting-Impact on Physical Activity and Fatigue. Kisch, A., Jakobsson, S., Forsberg, A.[2020]

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

Citations

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Understanding the Implementation of Cued Exercise Using ... The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an ...

2. clin.larvol.com clin.larvol.com/trial-detail/NCT06645132

Understanding the Implementation of Cued Exercise Using ... Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant. P=NA. Medical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10933580/

Application of wearables for remote monitoring of oncology ... This review aims to systematically map and categorize the current state of wearable applications among oncology patients and to identify determinants impeding ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11059679/

Utility and usability of a wearable system and progressive ... This study demonstrates that a low-cost wearable system providing frequent haptic cues to encourage graded-challenge exercise after stroke can have utility.

5. viterbischool.usc.edu viterbischool.usc.edu/news/2021/02/wearable-fitness-trackers-useful-in-cancer-treatment-study-finds/

Wearable Fitness Trackers Useful in Cancer Treatment ... Enter the wearable activity tracker system: a Microsoft Band 2, which tracks steps, heart rate and calories expended, and a Microsoft smartphone ...

6. biotechhunter.com biotechhunter.com/trials/NCT06645132

Understanding the Implementation of Cued Exercise Using ... Exercise intervention leveraging wearable devices and a custom smartphone application to cue exercise as a reminder during idle time during an inpatient ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38685012/

Utility and usability of a wearable system and progressive ... This study demonstrates that a low-cost wearable system providing frequent haptic cues to encourage graded-challenge exercise after stroke can have utility.