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Hematopoietic Stem Cell TransplantationNCT06907004

Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

An observational study of Hematopoietic Stem Cell Transplantation, run by Chimei Medical Center at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Hematopoietic Stem Cell Transplantation
How many people
24 participants
Where
1 siteTaiwan
Study dates
14 Feb 2023to 13 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: First-time hematopoietic stem cell transplantation (HSCT) patients and their primary caregivers, and physical therapists and nurses at Chimei Medical Center.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chimei Medical Center

    Tainan, Taiwan, 71004

Other trials in Taiwan

About this study

Official title: Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation: An Action Research Approach.

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.

Read more

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.

Keywords
Action research, Hematopoietic stem cell transplantation, Exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise adherence rate

    Definition: The percentage of prescribed exercise sessions completed by participants during the hematopoietic stem cell transplantation hospitalization period.

    Measurement Method:

    1. Numerator: Number of completed exercise sessions
    2. Denominator: Total number of prescribed exercise sessions
    3. Unit of Measure: Percentage (%)

    Measured: approximately 4-6 weeks

  2. Patient Satisfaction Score of the Exercise Program

    Definition: The mean score of a 7-item satisfaction questionnaire using a 5-point Likert scale to evaluate patient's satisfaction with the exercise program.

    Measurement Method:

    1. Tool: 7-item satisfaction questionnaire with 5-point Likert scale Scale Range: 1 (strongly disagree) to 5 (strongly agree)
    2. Total Score Calculation: Mean score of all 7 items
    3. Unit of Measure: Score on a scale (1-5)

    Questionnaire Items:

    1. Appropriateness of exercise timing
    2. Appropriateness of exercise intensity
    3. Appropriateness of exercise frequency
    4. Appropriateness of exercise type and difficulty level
    5. Achievement of exercise goals
    6. Satisfaction with personal performance
    7. Willingness to continue exercising

    Measured: approximately 4-6 weeks

  3. Exercise-Related Adverse Events Rate

    Definition: The percentage of exercise sessions with adverse events during the hematopoietic stem cell transplantation hospitalization period.

    Measurement Method:

    1. Numerator: Number of exercise sessions with adverse events
    2. Denominator: Total number of completed exercise sessions
    3. Unit of Measure: Percentage (%)

    Measured: approximately 4-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start14 Feb 2023
  3. Primary completion13 Oct 2023
  4. Study completion13 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907004
Sponsor's protocol ID
11111-006
Status last verified
Feb 2023
First submitted
19 Mar 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to the following reasons: 1. Privacy and confidentiality concerns - The study involves sensitive medical information from HSCT patients and personal experiences from healthcare providers. 2. Ethical restrictions - The informed consent obtained from participants did not include permission for data sharing beyond the research team. 3. Hospital policy compliance - The participating medical center's regulations restrict the sharing of patient-related data to protect patient privacy. 4. Small sample size - With only 24 participants, sharing individual data might risk participant identification, even if anonymized.

Publications

  • 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.

    PubMed 32075567

  • 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.

    PubMed 23252444

  • 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.

    PubMed 30653940

  • 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.

    PubMed 30277514

  • 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.

    PubMed 21132025

  • 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.

    PubMed 31626055

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic Stem Cell Transplantation, run by Chimei Medical Center at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise adherence rate (time frame: approximately 4-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907004, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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