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

Sponsor
Ruijin Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401045
Collaborator
(none)
119
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Met exercises
 N/A

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.

  1. 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.

  2. 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.)

  3. Recording: Each participant completed a form after each exercise session.

  4. 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of a Self-designed Metabolic Equivalent Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: observation group

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). 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.

Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Fatigue state using the Revised Piper Fatigue Scale (RPFS) [up to 3 months]

    Cancer-related fatigue is distressing persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning. To use the Revised Piper Fatigue Scale (RPFS) to investigate the fatigue state.The RPFS includes 22 items and 3 open-ended questions regarding the duration of fatigue, the possible causes of fatigue, fatigue-influencing factors, measures to relieve fatigue, and symptoms related to fatigue[7]. The 22 items address the degree that fatigue affects daily activities (6 items), emotional (5 items) and physical (5 items) factors that affect fatigue, and the cognitive and emotional statuses of the respondent (6 items). A number from 0 to 10 is used to indicate the degree of fatigue, with 0 indicating no fatigue and 10 the most severe fatigue; the higher the score is, the more severe the fatigue is.

Secondary Outcome Measures

  1. Quality of life using the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30) [up to 3 months]

    Quality of life refers to a person's feeling of life, is a concept of comprehensive evaluation of the pros and cons of life, usually refers to a result of the development of social policies and plans, mainly refers to the state assessment of individual physical, psychological and social functions. We use the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30) to measure. The scale has a total of 30 items that are evaluated in 5 functional areas (physical, role, emotional, cognitive, and social dimensions). The higher the functional field and overall scores are, the higher the quality of life of the respondent is; the higher the symptom field scores are, the worse the quality of life is.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Principal Investigator: Lei Huang, PhD, MD, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
lei huang, Research Associate Fellow; PI, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05401045
Other Study ID Numbers:
  • RJHK-2020-16
First Posted:
Jun 2, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Aug 12, 2022