Effect of a Self-designed MET Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer
NCT ID: NCT05401045
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2023-01-20
2023-07-29
Brief Summary
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Detailed Description
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For the SMEE group:
1. The general information questionnaire, RPFS, and the Chinese version of the EORTC QLQ-C30 (V3.0) were used for the baseline assessment of patients, and intervention was performed for patients with an RPFS score greater than or equal to 1.
2. Exercise plan: Each session of the SMEE program was divided into 8 components: Stretching exercises, chest expansion exercises, kicking exercises, lateral movement exercises, body rotation exercises, whole-body exercises, jumping exercises, and a cooldown. There were 4 sets and 8 repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening. For patients with moderate fatigue and with an RPFS score of 4 to 6 points, low-intensity exercises were recommended, i.e., patients could choose 1 to 4 metabolic equivalent exercises and repeat them twice; for patients with mild fatigue and with an RPFS score of 1 to 3 points, moderate-intensity exercises were recommended, i.e., patients could choose to complete the entire set of metabolic equivalent exercises or 5 to 8 of the exercises and repeat them twice. The exercise frequency was 5 times per week. Nurses informed the participants of the precautions for exercises to ensure safe implementation.
Metabolic equivalent intensity: The intensity of exercises was expressed as metabolic equivalents (METs). For this study, greater than or equal to 6 METs indicated high intensity, 3 to 5.9 METs moderate intensity, and less than 3 METs low intensity.
3. Exercise training: Members of the Fatigue Management Team in the ward taught the patients to perform metabolic equivalent exercises using videos. Exercise guidance was provided after assessments of surgical, catheter, and incisional pain. Patients could follow the department's WeChat public account to watch complete videos pertaining to metabolic equivalent exercises and related exercise precautions. The Fatigue Management Team members confirmed that a patient could perform the exercise independently and correctly.
4. Health education: The participants were provided with information related to CRF (causes, clinical manifestations, associated factors, the necessity and importance of fatigue prevention, and measures to reduce CRF, etc.) and exercises (intensity, time, frequency, precautions, etc.)
5. Recording: Each participant completed a form after each exercise session.
6. Follow-up: A nurse followed up with each patient by telephone every 2 weeks to determine if the patient completed his or her exercise sessions. Exercise completion rate (%)=(actual exercise time÷planned exercise time)×100%. Nurses supervised and provided reminders to patients with completion rates below 50%. In addition, each patient's exercise success rate was calculated: Exercise success rate (%)=(real-time heart rate after exercise÷target heart rate)×100% (\>70% was considered to be up to standard). Target heart rate=(200-age)×100%; a heart rate of 70% to 80% of the target heart rate could improve cardiopulmonary function.
For the control group:
Participants received routine exercise health education that included information pertaining to CRF (causes, clinical manifestations, associated factors, the necessity and importance of fatigue prevention, and measures to reduce CRF, etc.) and exercises (3-5 times per week, regardless of the type of exercises). The patients were also informed of the precautions for exercise.
After 3 months, the SMEE and the control groups were reassessed using the RPFS and the Chinese version of the EORTC QLQ-C30 (V3.0).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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observation group
1. Exercise plan: Each session of the self-designed METexercises were divided into 8 components. There are 4 sets and 8-repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening.Metabolic equivalent intensity: The intensity of exercise was expressed as metabolic equivalents (METs).
2. Exercise training: Members of the fatigue management team in the ward taught the patients to perform MET exercises using videos.The fatigue management team members confirmed that the patient could perform the exercise independently and correctly.
Met exercises
Exercise plan: Each session of the self-designed MET exercise program was divided into 8 components: stretching exercises, chest expansion exercises, kicking exercises, lateral movement exercises, body rotation exercises, whole-body exercises, jumping exercises, and a cool down. There are 4 sets and 8-repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening. For patients with moderate fatigue and an RPFS score of 4 to 6 points, low-intensity exercise was recommended, i.e., patients could choose 1 to 4 metabolic equivalent exercises and repeat them twice; for patients with mild fatigue and an RPFS score of 1 to 3 points, moderate-intensity exercise was recommended, i.e., patients could choose to complete the entire set of metabolic equivalent exercises or 5 to 8 of the exercises and repeat them twice. The exercise frequency was 5 times per week.
control group
Participants received routine exercise health education that included information pertaining to CRF (causes of CRF, clinical manifestations, related factors, the necessity and importance of fatigue prevention, and measures to improve CRF, etc.) and exercise (3-5 times per week, regardless of the type of exercise). The patients were also informed about the precautions for exercise.
No interventions assigned to this group
Interventions
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Met exercises
Exercise plan: Each session of the self-designed MET exercise program was divided into 8 components: stretching exercises, chest expansion exercises, kicking exercises, lateral movement exercises, body rotation exercises, whole-body exercises, jumping exercises, and a cool down. There are 4 sets and 8-repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening. For patients with moderate fatigue and an RPFS score of 4 to 6 points, low-intensity exercise was recommended, i.e., patients could choose 1 to 4 metabolic equivalent exercises and repeat them twice; for patients with mild fatigue and an RPFS score of 1 to 3 points, moderate-intensity exercise was recommended, i.e., patients could choose to complete the entire set of metabolic equivalent exercises or 5 to 8 of the exercises and repeat them twice. The exercise frequency was 5 times per week.
Eligibility Criteria
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Inclusion Criteria
* Clear pathological diagnosis and staging;
* Undergoing chemotherapy
* CRF based on a total score ≥1 on the revised Piper Fatigue Scale (RPFS) after admission;
* CRF with a Barthel index greater than 80 points;
* Agreed to participate voluntarily and signed an informed consent form;
* Life expectancy of at least 3 months
Exclusion Criteria
* Patients with mental disorders and unable to communicate verbally;
* Patients with sudden changes in the disease course.
18 Years
85 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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lei huang
Research Associate Fellow; PI
Principal Investigators
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Lei Huang, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Ruifeng Z. The influencing Factors of Cancer-Related Fatigue in gastric cancer patients in perioperative period[D].Dalian：Dalian Medical School,2017
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Lian L, Linhui Z, Mingqin C. Advances in diagnostic and assessment scales for cancer-caused fatigue[J].XinJiang Medicine,2016,46(11):1458-1461,1465
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Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.
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GLOBOCAN 2020. Estimated number of of new cases of new cases in 2020, China, both sex, alll ages. [EB/OB]https://gco.iarc.fr/today
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Related Links
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GLOBOCAN 2020
Other Identifiers
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RJHK-2020-16
Identifier Type: -
Identifier Source: org_study_id