Muscle Stimulation for Physical Function During Stem Cell Transplant
Maneno muhimu
Kikemikali
Maelezo
Hematopoietic cell transplantation (HCT) reduces physical function and muscle mass and increases fatigue. Neuromuscular electrical stimulation (NMES), when used as a stand-alone intervention, improves muscle strength and muscle mass in non-cancer patients with chronic obstructive pulmonary disease and chronic heart failure. The use of NMES to combat disuse atrophy and functional decline may be particularly useful in the HCT setting as patients undergo intensive preparatory chemotherapy and often experience symptoms including severe fatigue that leave them inactive or isolated for extended time periods surrounding the transplant. However, its use in the setting of cancer has not been well-established. This proposal will contribute to developing strategies toward optimizing the safety and outcomes associated with HCT in Veterans with hematologic malignancies. The overall goals of this study are to assess 1) the efficacy of an NMES vs Sham intervention on HCT-induced reductions in physical function and muscle mass and worsening of patient-reported fatigue and QOL and 2) the association between physical function and prolonged recovery of patient-reported fatigue and QOL. The investigators hypothesize that 1) NMES will attenuate the acute HCT-induced negative impact on physical function, body composition, QOL, and fatigue compared to Sham intervention, and 2) baseline physical function will be a significant predictor of 6-month recovery of patient-reported fatigue and QOL. Aim 1: To determine the efficacy of NMES vs. Sham for attenuation of HCT-induced reductions in physical function, muscle mass, and patient-reported QOL and fatigue in patients undergoing autologous HCT. Patients will be randomized 1:1 (NMES:Sham) stratified by diagnosis. Physical function, body composition, QOL, and fatigue will be assessed at baseline (Pre, after admission to the Bone Marrow Transplant Unit but before initiation of preparatory chemotherapy) and 28 plus or minus 5 days after HCT (Follow-up 1; FU1). The primary outcome will be between-group difference in 6MWT change at FU1 compared to Pre (N=23/group; 46 total). Secondary outcomes include: body composition measured by dual-energy x-ray absorptiometry; previously validated questionnaires (Functional Assessment of Chronic Illness Therapy-Fatigue; Muscle and Joint Measures) to assess patient-reported fatigue, QOL, symptom burden, and functional status; standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, treatment history, functional status, and clinical course; and NMES process measures such as feasibility, acceptability, adherence in number of sessions, accurate use, duration/intensity, complications, and satisfaction. Aim 2: To determine predictive ability of baseline 6MWT on delayed recovery of physical function, QOL, and fatigue, patient-reported outcomes, physical function, and chart review will be collected 6-months after HCT (FU2). 6MWT at Pre will be used to determine significant predictors of QOL and fatigue at FU2 (N=46) as assessed by previously validated questionnaires. Clinical measures extracted from medical charts will include changes from FU1 to FU2 in standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, functional status, treatment history, disease trajectory, and survival. Aim 3 (exploratory): To investigate the acute impact of NMES vs. Sham during HCT on various aspects of physical function and patient-reported QOL for determining potential endpoints for future clinical trials. Exploratory measures of function (stair climbing power; muscle strength; sit-to-stand; handgrip strength; peak oxygen consumption) assessed at Pre and FU1 will be used to determine significant predictors of exploratory QOL measures (Multidimensional Fatigue Inventory; Short Form-36; European Organization for Research and Treatment of Cancer QOL Questionnaire) assessed at FU2.
Tarehe
| Imethibitishwa Mwisho: | 03/31/2020 |
| Iliyowasilishwa Kwanza: | 04/19/2020 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 04/22/2020 |
| Iliyotumwa Kwanza: | 04/27/2020 |
| Sasisho la Mwisho Liliwasilishwa: | 04/27/2020 |
| Sasisho la Mwisho Lilichapishwa: | 04/28/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 01/03/2021 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 12/31/2024 |
| Tarehe ya Kukamilisha Utafiti: | 09/30/2025 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Active NMES asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction. | |
| Sham Comparator: Sham NMES The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - adequate cognitive and language ability to provide consent - Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT Exclusion Criteria: - active deep vein thrombosis or thrombophlebitis - untreated hemorrhagic disorders - concomitant study inclusion in other nutritional or physical exercise interventional trials - concomitant use of anabolic agents - rhabdomyolysis or other muscle conditions where NMES is contraindicated |
Matokeo
Hatua za Matokeo ya Msingi
1. 6-Minute Walk Test [change from before to 1month after transplant]
Hatua za Matokeo ya Sekondari
1. Patient-reported Fatigue [change from before to 1month after transplant]
2. Lean Body Mass [change from before to 1month after transplant]
3. Physical Activity [change from before to 1month after transplant]
4. NMES adherence [1month after transplant]
5. Muscle Damage (safety) [change from before to 2 weeks after intervention initiation]
6. Muscle Damage (safety) [change from before to 4 weeks after intervention initiation]
7. Muscle Damage (safety) [change from before to 6 weeks after intervention initiation]
8. Muscle Damage (safety) [change from before to 8 weeks after intervention initiation]
9. Muscle Damage (safety) [change from before to 1month after transplant]
10. 6-Minute Walk Test [change from before to 6 months after transplant]
11. Patient-reported Fatigue [change from before to 6 months after transplant]
12. Physical Activity [change from before to 6 months after transplant]
