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

15 Participants Needed

Trial Summary

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 data supports the idea that Exercise Intervention for Blood Cancer Patients Post-Transplant is an effective treatment?

The available research shows that exercise interventions for blood cancer patients post-transplant can be effective. One study found that exercise had a moderately positive effect on fitness, muscle strength, and reducing fatigue. Another study showed that patients who participated in an exercise program improved their walking distance before their transplant. Additionally, a pilot study of a home-based exercise program reported improvements in fitness and well-being without any exercise-related issues. These findings suggest that exercise can help improve physical health and quality of life for these patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Cued Exercise Using Wearable Devices and a Custom Smartphone Application for blood cancer patients post-transplant?

Research shows that exercise can improve physical fitness, reduce fatigue, and enhance quality of life in patients who have undergone stem cell transplantation. Wearable devices have been found to help people with chronic illnesses stick to exercise routines, suggesting they could be useful for blood cancer patients post-transplant as well. ^{1 2 3 4 5}

What safety data exists for exercise interventions in blood cancer patients post-transplant?

The available safety data for exercise interventions in blood cancer patients post-transplant indicates that such programs are generally safe. In a pilot study of a home-based aerobic exercise program for hematopoietic stem cell transplant recipients, no exercise-related adverse events were reported. A feasibility randomized controlled trial of exercise before, during, and after allogeneic hematological stem cell transplant reported one serious adverse event during a baseline test, but no adverse events were associated with the exercise intervention itself. Additionally, a systematic review on exercise interventions in patients with hematological cancer undergoing chemotherapy highlighted the need for more research but did not report significant safety concerns. Overall, these studies suggest that exercise interventions are feasible and safe, though further high-quality research is needed to confirm these findings and optimize exercise protocols. ^{3 4 5 6 7}

Is exercise intervention safe for blood cancer patients post-transplant?

Research shows that exercise interventions, including those using wearable devices and smartphone apps, are generally safe for cancer patients, including those who have undergone stem cell transplants. No exercise-related adverse events were reported in several studies, indicating that these interventions are safe for human use. ^{3 4 5 6 7}

Is the treatment 'Cued Exercise Using Wearable Devices and a Custom Smartphone Application' promising for blood cancer patients after transplant?

Yes, the treatment is promising because exercise has been shown to improve physical fitness, reduce fatigue, and enhance quality of life for blood cancer patients after transplant. Using wearable devices and smartphone apps can help patients stick to their exercise routines, making it easier to overcome barriers to regular exercise. ^{2 3 4 5 8}

How is the treatment 'Cued Exercise Using Wearable Devices and a Custom Smartphone Application' different from other treatments for blood cancer patients post-transplant?

This treatment is unique because it uses wearable devices and a smartphone app to provide personalized exercise reminders, which can help patients maintain an exercise routine more easily compared to traditional methods. This approach leverages technology to overcome barriers to exercise, potentially improving physical fitness and quality of life for patients after stem cell transplantation. ^{2 3 4 5 8}

What is the purpose of this trial?

The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. [2020]

4. Netherlands 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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