Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

March 31, 2025 updated by: Chimei Medical Center

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan City, Taiwan, 71004
        • ChiMei Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise adherence rate
Time Frame: approximately 4-6 weeks

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 (%)
approximately 4-6 weeks
Patient Satisfaction Score of the Exercise Program
Time Frame: approximately 4-6 weeks

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
approximately 4-6 weeks
Exercise-Related Adverse Events Rate
Time Frame: approximately 4-6 weeks

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 (%)
approximately 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chimei Medical Center

Investigators

  • Principal Investigator: Min-Syuan Yen, Master's Degree, ChiMei Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Actual)

October 13, 2023

Study Completion (Actual)

October 13, 2023

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11111-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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