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临床试验/NCT05401045
NCT05401045已完成不适用

Effect of a Self-designed Metabolic Equivalent Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
1
主要终点
Fatigue state using the Revised Piper Fatigue Scale (RPFS)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Fatigue state using the Revised Piper Fatigue Scale (RPFS)

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

lei huang

Research Associate Fellow; PI

Ruijin Hospital

研究点 (1)

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