Clinical trial · Interventional
Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
Adherence, Feasibility, Clinical Evolution Therapeutic Efficacy of Three Different Muscle Overload Models Used for Physical Rehabilitation of Patients Undergoing Bone Marrow Transplantation: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). However, the adverse effects of this treatment affect multiple organs and systems, reducing physical capacity, increasing the feeling of fatigue, anxiety and depression, which together affect quality of life. Patients who exercise before, during or after anti-neoplastic treatment demonstrate significant benefits. But rehabilitating physical capacity involves the challenge of fluctuations in the patient's readiness along with daily clinical variations, which ultimately directly affects the rate of adherence to exercises, impacting the effectiveness of the physical rehabilitation program. There is no specific individualization of muscular overload that takes into account such variability in pathophysiological, functional and psychological situations, but the cardiorespiratory response and muscular strength performance in the face of progressive overload can be measured with sufficient recovery periods to optimize the physiological adaptations promoted by muscular overload. regularly, even in patients undergoing antineoplastic treatment. Objective: To evaluate the adherence rate, operational feasibility, clinical/behavioral evolution and effectiveness of three different muscle overload models (aerobic, anaerobic and mixed) used for the physical rehabilitation of patients hospitalized for antineoplastic hematological treatment with HSCT
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cycle ergometer | Device | — | UNRESOLVED |
| Cycle ergometer, elastic band and shin guards | Device | — | UNRESOLVED |
| Strength Training - elastic band and shin guards | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aerobic Exercise Group
- description
- Aerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age).
- interventionNames
- Device: Cycle ergometer
- type
- EXPERIMENTAL
- label
- Anaerobic Exercise Group
- description
- Muscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds.
- interventionNames
- Device: Strength Training - elastic band and shin guards
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion criteria: * Be between 18 and 64 years old; * Present hematological malignancy undergoing first antineoplastic treatment with HSCT; * Have intact neurological function and cognition; * Be in clinical conditions that allow participation in physical rehabilitation; * To agree with the study proposal by signing the Free and Informed Consent Form (TCLE). Exclusion criteria: * Present clinical complications that impair the performance of motor physiotherapy, including the practice of cycle ergometer and resistance exercises; * Present previous musculoskeletal changes that interfere with the execution of physical performance assessment tests; * Patients with limiting cardiovascular or pulmonary disease, significant psychiatric or neurological disorders and/or limiting interpretation of documents and forms that will be used in the study; * Patients who require mobility assistance and/or diagnosed with multiple myeloma with or without the presence of bone metastasis;
References
Publications (42)
- BACKGROUNDWehrle A, Kneis S, Dickhuth HH, Gollhofer A, Bertz H. Endurance and resistance training in patients with acute leukemia undergoing induction chemotherapy-a randomized pilot study. Support Care Cancer. 2019 Mar;27(3):1071-1079. doi: 10.1007/s00520-018-4396-6. Epub 2018 Aug 18. PMID 30121789
- BACKGROUNDvan Haren IE, Timmerman H, Potting CM, Blijlevens NM, Staal JB, Nijhuis-van der Sanden MW. Physical exercise for patients undergoing hematopoietic stem cell transplantation: systematic review and meta-analyses of randomized controlled trials. Phys Ther. 2013 Apr;93(4):514-28. doi: 10.2522/ptj.20120181. Epub 2012 Dec 6. PMID 23224217
- BACKGROUNDTran J, Norder EE, Diaz PT, Phillips GS, Elder P, Devine SM, Wood KL. Pulmonary rehabilitation for bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Aug;18(8):1250-4. doi: 10.1016/j.bbmt.2012.01.017. Epub 2012 Jan 30. PMID 22300617
- BACKGROUNDTHOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available. PMID 13837954
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDSteinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14. PMID 25971213
- BACKGROUNDStorb R, Sandmaier BM. Nonmyeloablative allogeneic hematopoietic cell transplantation. Haematologica. 2016 May;101(5):521-30. doi: 10.3324/haematol.2015.132860.