- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203301
The Relationships of Resistance Exercise, Walking, Myokine Secretion, Sarcopenia, Muscle Loss, Quality of Life, and Predictors in Cancer Patients Receiving Chemoradiotheray
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hsiu Ting Tsai
- Phone Number: 6337 886-2-27361661
- Email: hsiuting@tmu.edu.tw;tsaihsiuting@yahoo.com.tw
Study Contact Backup
- Name: Sun Chia Hsuan
- Phone Number: 886+928894620
- Email: m432110019@tmu.edu.tw
Study Locations
-
-
Taipei Taiwan
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Taipei city, Taipei Taiwan, Taiwan, 110301
- Recruiting
- Taipei Medical University Hospital
-
Contact:
- Hsiu Ting Tsai
- Phone Number: 6337 886-2-27361661
- Email: hsiuting@tmu.edu.tw;tsaihsiuting@yahoo.com.tw
-
Contact:
- Chai Hsuan Sun
- Phone Number: 886+928894620
- Email: m432110019@tmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cancer patients receiving chemoradiotherap
- age 20-70 years old
- participants who are available for doing resistance exercise and/or walking after physical assessment by physician
- education level >=elementary school
Exclusion Criteria:
- Participants can't speak Mandarin, Taiwanese, or Hakka language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
No exercise intervention measures will be implemented.
The patient will carry out daily life according to his past living habits and continue to be followed for at least one year.
|
|
Experimental: resistance exercise group
Resistance exercise training begins before the patient undergoes concurrent chemoradiotherapy, radiotherapy, or chemotherapy.
The patients were given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks.
After that, the patient is asked to regularly perform resistance exercise for at least 1 year.
|
After receiving the cases, they were divided into 4 groups by random allocation:
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Experimental: walking group
Walking training begins before the patient undergoes simultaneous radiochemotherapy, radiation therapy, or chemotherapy, and requires continuous walking for 15 minutes at least twice a day and at least 5 days a week.
Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walking training.
After that, ask the patient to walk regularly for at least 1 year.
|
After receiving the cases, they were divided into 4 groups by random allocation:
|
Experimental: resistance exercise and walking group
Before patients receive concurrent chemoradiotherapy, radiotherapy, or chemotherapy, they are given resistance exercise training and walking training for 12 consecutive weeks.
After that, the patient is asked to regularly perform resistance exercise and walking for at least 1 year.
|
After receiving the cases, they were divided into 4 groups by random allocation:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical functional performance
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
|
This study plans to use the 5-time stand-up-sit test to assess physical functional performance.
Five stand-up and sit-down tests lasting more than or equal to 12 seconds indicate that the patient's physical function performance is reduced.During the measurement, the patient is asked to sit on a chair about 40cm above the ground.
The back of the chair is against the wall.
The patient is asked to sit down against the back of the chair.
The patient is asked to stand up.
The patient is asked to do his best to stand up and stand upright five times continuously and without interruption.
Sit down, keeping your hands folded on your chest.During the test, the patient stood up once and was asked to count the sounds.
The test ended when the patient stood up for the fifth time.
|
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
|
muscle strength
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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Measuring the patient's muscle strength with a handgrip dynamometer(Hand Grip Strength, EH101, CAMYR, Guangdong)
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From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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muscle mass
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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In order to avoid radiation exposure when patients undergo testing and to facilitate repeated measurements, this research plan will use the Bioelectrical Impedance Analyzer (BIA) Inbody S10 to detect the skeletal muscle mass of the limbs of patients.
The bioelectrical impedance analyzer is currently a commonly used analyzer for clinical measurement of body composition, using microcurrent to measure the human body.
|
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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the incidence of sarcopenia
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
|
The assessment of sarcopenia in this study uses the Asian Working Group for Sarcopenia (AWGS) diagnostic criteria as the criteria for screening sarcopenia, including: (1) low muscle strength: handgrip strength <28 kg for men, women <18 kg; (2) low physical performance: 5 stand-up and sit-down tests greater than or equal to 12 seconds; (3) loss of appendicular skeletal muscle mass (ASM): bioelectrical impedance analysis (BIA) men <7.0kg/m2, women <5.7kg/m2. If the skeletal muscle mass of the limbs is reduced combined with weakened muscle strength or physical functional performance, it is called sarcopenia; if the skeletal muscle mass of the limbs is reduced, the muscle strength is weakened, and the physical functional performance is reduced at the same time, it is severe sarcopenia. |
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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effectively improve their quality of life
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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This study uses the Functional Assessment of Cancer Therapy-General (FACT-G) to assess the quality of life of patients.
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From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
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The concentration of muscle hormones in the blood of cancer patients undergoing treatment
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
|
The specimen is collected based on the principle of collecting 5 mL of venous blood. The blood is injected into a special biochemical test tube containing Lithium heparin, an anticoagulant, and mixed gently to avoid blood coagulation and hemolysis. Centrifuge at 3500 rpm for 10 minutes, and separate the upper plasma for detection of muscle hormones in the blood, including: myonectin, irisin, decorin, fibroblast growth factor-21, interleukin-15, interleukin-6, myostatin, osteonectin, and brain-derived hormones. |
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- N202109030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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