Exercise Intervention for Blood Cancer Patients Post-Transplant
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Medical College of Wisconsin
No Placebo Group
Trial Summary
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.
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.
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.
12345What 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.
34567Is 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.
23458Eligibility 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 18 years old or older.
I am scheduled for a bone marrow transplant from a donor.
I have been diagnosed with a blood cancer.
+1 more
Exclusion Criteria
I cannot walk for 15 minutes without help.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Reminders to exercise through cues provided by wearable device + custom smartphone applicationExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert HospitalMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. [2009]To determine if therapist supervision of an exercise program produced better functional outcomes in allogeneic stem cell transplant patients than a patient-directed exercise program.
Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. [2023]Hematopoietic stem cell transplant (HSCT) is a potentially curative treatment for hematopoietic malignancies, complicated by decreased performance status and quality of life. Exercise therapy improves outcomes in HSCT, but several barriers have prevented exercise from becoming routine clinical practice. Based on existing data that wearable technologies facilitate exercise participation in other sedentary and chronic illness populations, we propose the novel hypothesis that wearable technologies are a valuable tool in transcending barriers and developing exercise therapy programs for HSCT patients.
Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. [2020]People with cancer who undergo allogeneic hematological stem cell transplant (allo-HSCT) experience significant deconditioning that can compromise quality of life. Exercise has shown to be beneficial before or after allo-HSCT; however, little is known about exercise therapy delivered across the continuum of care. We conducted a feasibility randomized controlled trial of exercise delivered prior to admission, during the inpatient stay, and after discharge versus control in people with planned allo-HSCT. Feasibility was assessed via recruitment and retention rates, the incidence of adverse events, and adherence to the exercise prescription. Estimates of efficacy were measured at baseline, one week prior to hospital admission, and 100 days and one year after transplant. The recruitment and retention rates were 20% and 33%, respectively. One serious adverse event occurred during the baseline six-minute walk test that precluded participation in the study and no adverse events were associated with the intervention. From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: -18.0 to 108.7)-a finding that warrants further investigation with an adequately powered trial. Our study contributes important feasibility considerations and pilot data for future exercise intervention research in allo-HSCT recipients.
Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. [2022]We performed a systematic review and meta-analysis evaluating the effectiveness of exercise interventions compared with usual care on physical fitness, fatigue and health-related quality of life in patients with hematologic malignancies treated with stem cell transplantation. Electronic databases were searched up to June 2012. We included randomized controlled trials comparing exercise with usual care, in which at least 75% of the patients had a hematologic malignancy. Standard mean differences were calculated and pooled to generate summary effect sizes (ES) and 95% confidence intervals (CI). The Cochrane Collaboration Risk of Bias Tool was used to assess the methodological quality of the studies. Eight studies met our inclusion criteria. Exercise had a statistically significant moderately favourable effect on cardiorespiratory fitness (ES=0.53, 95% CI=0.13-0.94), lower extremity muscle strength (ES=0.56, 95% CI=0.18-0.94) and fatigue (ES=0.53, 95% CI=0.27-0.79). Significant small positive effects were found for upper extremity muscle strength, global quality of life, and physical, emotional and cognitive functioning. In conclusion, exercise seems to have beneficial effects in patients treated with stem cell transplantation. However, all studies had at least some risk of bias, and for cardiorespiratory fitness and lower extremity muscle strength substantial heterogeneity in effect sizes were observed. Further high quality research is needed to determine the optimal exercise intervention and clinical implications.
Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. [2022]We report a pilot study of a home-based aerobic exercise program in a group of 17 adult hematopoietic stem cell transplant (HSCT) recipients. Participants had received no cancer treatment for at least 6 months and reported leisure time physical activity less than 20 min per day and fewer than three times a week during the previous month. Following baseline assessments of aerobic fitness, fatigue symptoms, and quality of life, participants were placed on home-based aerobic exercise programs consisting of 20-40 min of activity in the target heart rate zone (40-60% predicted heart rate reserve) delivered in three to five sessions per week for 12 weeks. Subjects were supplied with electronic heart rate monitors and we encouraged program adherence using weekly telephone contacts and exercise diaries. In all, 32 of the 42 qualified candidates consented (acceptance=76%). Of these, 17 kept appointments for baseline assessments, four did not complete the study (attrition=46%), and no exercise-related adverse events were reported. Scores on measures of aerobic fitness, fatigue severity, and physical well-being improved (signed ranks test; P
Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]Exercise during and after cancer treatment has established quality of life and health benefits. However, particularly for patients with hematological cancer clear recommendations regarding the safety and feasibility of exercise are under-investigated. The aim of our systematic review was to summarize the literature regarding the feasibility and safety of exercise interventions in patients diagnosed with hematological cancer undergoing chemotherapy.
A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. [2022]Many older patients with myeloid neoplasms experience treatment-related toxicities. We previously demonstrated that a home-based, progressive aerobic walking and resistance exercise program (EXCAP) improved physical and psychological outcomes in patients with cancer. However, older patients have more difficulty adhering to exercise than younger patients. Reasons may include low motivation, difficulty with transportation, and limited access to exercise professionals. To improve exercise adherence, we integrated a mobile app with EXCAP (GO-EXCAP) and assessed its feasibility and usability in a single-arm pilot study among older patients with myeloid neoplasms undergoing outpatient chemotherapy. GO-EXCAP intervention lasts for 2 cycles of treatment, and the primary feasibility metric was data reporting on the app. Usability was evaluated via the system usability scale (SUS). Patients were interviewed at mid and postintervention to elicit their feedback, and deductive thematic analysis was applied to the transcripts. Twenty-five patients (mean age, 72 years) were recruited. Recruitment and retention rates were 64% and 88%, respectively. Eighty-two percent (18/22) of patients entered some exercise data on the app at least half of the study days, excluding hospitalization (a priori, we considered 70% as feasible). Averaged daily steps were 2848 and 3184 at baseline and after intervention, respectively. Patients also performed resistance exercises 26.2 minutes per day, 2.9 days per week at low intensity (rate of perceived exertion 3.8/10). Usability was above average (SUS, 70.3). In qualitative analyses, 3 themes were identified, including positive experience with the intervention, social interactions, and flexibility. The GO-EXCAP intervention is feasible and usable for older patients with myeloid neoplasms undergoing outpatient chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT04035499.
Implementing a Feasible Exercise Programme in an Allogeneic Haematopoietic Stem Cell Transplantation Setting-Impact on Physical Activity and Fatigue. [2020]Physical exercise for patients treated with allogeneic haematopoietic stem cell transplantation (allo-HSCT) has shown positive effects on the quality of life and fatigue in experimental trials. However, there is a need for longitudinal evaluation of exercise programmes implemented in a real-world clinical setting. The aim of this prospective study was to evaluate the impact of an exercise programme introduced before allo-HSCT on physical activity and fatigue before, during and after in-patient care. A structured exercise programme, including strength and endurance exercises, was implemented at a Swedish university hospital four weeks before transplantation, continuing during in-patient care and after discharge. Between March 2016 and May 2018, 67 adult patients, 33 women and 34 men with a mean age of 55.5 years participated. Fatigue was measured by the Multidimensional Fatigue Inventory at four time points. The patients documented their exercises on a checklist each week during the entire study period. The fatigue trajectory differed between various sub-groups, thus individualized supervision and support to maintain motivation is needed. In conclusion, a structured yet realistic exercise programme before admission is beneficial for allo-HSCT patients in order to reduce fatigue and prepare them for transplantation both physically and mentally.