Clinical trial NCT05401045: Effect of a Self-designed MET Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer
Official title: Effect of a Self-designed Metabolic Equivalent Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm of Stomach
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue state using the Revised Piper Fatigue Scale (RPFS)
timeFrame: up to 3 months
Secondary outcomes:
measure: Quality of life using the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30)
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Lei Huang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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