Effect of a Self-designed MET Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer (SMEE)

Shanghai Jiao Tong University

Status: Completed

Conditions: Neoplasm of Stomach

Treatments: Behavioral: Met exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05401045

RJHK-2020-16

Details and patient eligibility

About

To investigate the effect of using Self-arranged Metabolic Equivalent Exercises on cancer-related fatigue in gastric cancer patients. Gastric cancer patients admitted to the oncology department of a tertiary hospital in Shanghai were selected as study subjects and randomly divided into observation group and control group. The experimental group used Metabolic Equivalent Exercises for intervention besides exercise education and implemented records. In the control group, conventional exercise catharsis was performed. The Piper Revised Fatigue Scale (RPFS) and QLQ-30 Quality of Life Scale were used to measure cancer-caused fatigue and quality of life in both groups at the first admission and after 3 months.

Full description

This study was a randomized controlled trial. The subjects were randomly assigned into a SMEE or a control group.

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).

Enrollment: 119 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older;
• 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 heart, lung, liver, kidney and other vital organ failure;
• Patients with mental disorders and unable to communicate verbally;
• Patients with sudden changes in the disease course.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

observation group

Experimental group

Description:

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.

Treatment:

Behavioral: Met exercises

control group

No Intervention group

Description:

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.