Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chimei Medical Center

Tainan, Taiwan, 71004

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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:
- Numerator: Number of completed exercise sessions
- Denominator: Total number of prescribed exercise sessions
- Unit of Measure: Percentage (%)
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:
- Tool: 7-item satisfaction questionnaire with 5-point Likert scale Scale Range: 1 (strongly disagree) to 5 (strongly agree)
- Total Score Calculation: Mean score of all 7 items
- Unit of Measure: Score on a scale (1-5)
Questionnaire Items:
- Appropriateness of exercise timing
- Appropriateness of exercise intensity
- Appropriateness of exercise frequency
- Appropriateness of exercise type and difficulty level
- Achievement of exercise goals
- Satisfaction with personal performance
- Willingness to continue exercising
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:
- Numerator: Number of exercise sessions with adverse events
- Denominator: Total number of completed exercise sessions
- Unit of Measure: Percentage (%)

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Apr 2, 2025
Registry last updated: Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed