- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07709429
Qigong Exercise for Muscles Strength and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Muscle weakness and fatigue are prevalent side effects experienced by patients undergoing chemotherapy for colorectal cancer. These symptoms can significantly impact daily functioning and overall quality of life. Finding effective treatments for this condition is crucial to improving patient outcomes and quality of life.
Qigong serves as a holistic exercise modality that not only strengthens muscles but also elevates the overall quality of life. Its gentle movements make it accessible to a wide range of individuals, including those undergoing rehabilitation or managing chronic health issues.
Furthermore the need of this study is developed from lack in the quantitative knowledge and information in the published studies about the effect of Qigong on muscle strength and quality of life in colorectal cancer patients undergoing chemotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Phone Number: +20 12 71384571
- Email: Shorouq.mohamed@nub.edu.eg
Study Contact Backup
- Name: Khadra Mohammed Ali, PhD
Study Locations
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-
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Giza, Egypt
- Faculty of Physical Therapy, Cairo University
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Contact:
- Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Phone Number: +20 12 71384571
- Email: Shorouq.mohamed@nub.edu.eg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranges between 35 and 55 years.
- Male & female patients will participate in the study.
- All patients with colorectal cancer undergoing chemotherapy.
- All patients enrolled to the study will have their informed consent.
- The patients will be instructed to report any side effects during the management.
Exclusion Criteria:
- Presence Patients with psychological disturbance or mental illness.
- Cardiopulmonary disease.
- Hypotensive patients.
- Nerve, muscle, or joint disease, or other malignant tumors affecting movement.
- Autoimmune disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Qigong Exercise + Conventional Exercise Program
Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
|
Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
|
|
Active Comparator: Conventional Exercise Program
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
|
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: 12 weeks
|
Muscle strength of the upper and lower limbs will be assessed using the Lafayette Hand-Held Dynamometer.
Muscle strength will be quantified as the maximum isometric force generated by the tested muscle groups, with higher values indicating greater muscle strength.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life
Time Frame: 12 weeks
|
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
The questionnaire evaluates multiple domains of physical and mental health, with domain scores ranging from 0 to 100.
Higher scores indicate better health-related quality of life.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amal Mohammed Abd El Baky, PhD, Professor, Cairo University
- Study Director: Khadra Mohammed Ali, PhD, Assist Professor, Cairo University
- Study Director: Eid Rizk El Gamal, PhD, Assist. Professor, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005843
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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