Clinical trial NCT06907004: Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation: An Action Research Approach.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Action research
Hematopoietic stem cell transplantation
Exercise program
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-time hematopoietic stem cell transplantation (HSCT) patients and their primary caregivers, and physical therapists and nurses at Chimei Medical Center.

Brief summary: Background: Hematopoietic stem cell transplantation (HSCT) is a highly aggressive treatment, which is associated with numerous treatment-related side effects, such as fatigue and decreased functional activity. While recent studies have shown that physical exercise for patients undergoing HSCT is safe and feasible, and has a positive effect on the quality of life, fatigue, and lower limb muscle strength. However, there is no consensus regarding the intensity, type and frequency of exercise program, and few studies mention the patients' experience of exercise barriers and facilitators during HSCT. Therefore, the clinical implementation of exercise program is quite difficult.

Purpose: The purpose of this study is to develop a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.

Methods: Action Research is used to collect quantitative and qualitative data. Through the rolling revision of the exercise program during HSCT, finally develop a feasible exercise program.

Expected results: Developing a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

1. First-time hematopoietic stem cell transplantation (HSCT) patients who are ambulatory, their primary caregivers, and physical therapists and nurses participating in the exercise intervention;
2. Age 20 years or older;
3. Capable of understanding and complying with the study objectives;
4. No psychiatric disorders or cognitive impairments.

Exclusion Criteria:

1. HSCT patients deemed unsuitable for exercise participation based on the attending physician's assessment;
2. HSCT patients at risk of fractures or confined to bed rest due to musculoskeletal conditions.

Primary outcomes:
measure: Exercise adherence rate
timeFrame: approximately 4-6 weeks
measure: Patient Satisfaction Score of the Exercise Program
timeFrame: approximately 4-6 weeks
measure: Exercise-Related Adverse Events Rate
timeFrame: approximately 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Chimei Medical Center
Study officials:
affiliation: Chimei Medical Center
name: Min-Syuan Yen, Master's Degree
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morishita S, Nakano J, Fu JB, Tsuji T. Physical exercise is safe and feasible in thrombocytopenic patients with hematologic malignancies: a narrative review. Hematology. 2020 Dec;25(1):95-100. doi: 10.1080/16078454.2020.1730556.
citation: Morishita S, Kaida K, Setogawa K, Kajihara K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Safety and feasibility of physical therapy in cytopenic patients during allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2013 May;22(3):289-99. doi: 10.1111/ecc.12027. Epub 2012 Dec 18.
citation: Mohammed J, Aljurf M, Althumayri A, Almansour M, Alghamdi A, Hamidieh AA, ElHaddad A, Othman TB, Bazarbachi A, Almohareb F, Alzahrani M, Alkindi SS, Alsharif F, Da'na W, Alhashmi H, Bekadja MA, Al-Shammari SH, El Quessar A, Satti TM, Aljohani N, Rasheed W, Ghavamzadeh A, Chaudhri N, Hashmi SK. Physical therapy pathway and protocol for patients undergoing hematopoietic stem cell transplantation: Recommendations from The Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Group. Hematol Oncol Stem Cell Ther. 2019 Sep;12(3):127-132. doi: 10.1016/j.hemonc.2018.12.003. Epub 2019 Jan 11.
citation: Liang Y, Zhou M, Wang F, Wu Z. Exercise for physical fitness, fatigue and quality of life of patients undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials. Jpn J Clin Oncol. 2018 Dec 1;48(12):1046-1057. doi: 10.1093/jjco/hyy144.
citation: Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.
citation: Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.