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临床试验/NCT05696262
NCT05696262尚未招募不适用

Effects of 6-minute Walking Exercise in Advanced Cancer and Non-cancer Patients: a Randomized Controlled Trial

Taipei Medical University0 个研究点目标入组 120 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Steps count

研究概览

简要总结

This study was conducted with a single-blind, randomized control method for 120 participants, 60 in the regular care group and 60 in the exercise intervention group. Those who meet the admission criteria will be contacted by phone and explained the purpose of the study. After asking for and obtaining consent, those who are willing to sign the consent form will be divided into groups and go to the home with the home care worker for the study. A suitable space was arranged for a 6-minute explanation and demonstration of walking exercise and a structured questionnaire to be filled out by the participant (the Barr's scale, Koch's scale and cognitive function assessment in the basic data were filled out by the facilitator), and the facilitator accompanied the participant during the process, giving explanations for unclear points to facilitate the completion of the questionnaire and to achieve a valid questionnaire. A trained research assistant was responsible for recruiting cases and receiving a study number and corresponding group assignment. Stratified random assignment (1:1) was used to divide the exercise intervention group and the usual care group. The study was listed using a randomized use of replacement blocks (block size 4). The assignment sequence was only available to the program facilitator and was not known to the other staff. Interventional measures Routine care group: A primary care team of physicians and nurse practitioners visited at least once a month for: (1) an initial intake visit (60-90 minutes) to provide a holistic assessment of disease intensity and prognosis, psychological distress, and social support; (2) at least one home care visit per month (30-60 minutes); (3) a telephone (4) Provide caregivers with social software and telepresence to solve caregiving problems (5) Provide exercise diaries to record daily activities of daily living (including vital signs, mobility, and fatigue). Exercise intervention group: In addition to the regular care group model, the intervention measure: 6 minute walk test (6MWT) is the simplest and most cost effective way to assess exercise. Pre-intervention equipment: 6-minute walk exercise video, yardstick, distance marker cone, measuring tape, exercise diary, smart bracelet, all subjects were provided with 6-minute walk exercise video and related equipment by the facilitator at intake. Before the test: explain the pre and post-test precautions, demonstrate the correct way to perform the test, and inform the patient to perform the test in a comfortable manner. In addition, the case was asked to wear the bracelet 24 hours a day for 7 days a week to observe the sleep quality. During the intervention period, if a case has the following conditions, the principle of implementation is as follows: (1) if the case has good walking ability, the case will be reminded to comply with the intervention (or keep the original physical activity) through telephone care and exercise diary; (2) if the case is physically able to walk but has low willingness to perform the 6-minute walk due to various conditions, the case will be reminded by family members or followed up by the researcher by telephone to improve the implementation rate; (3) if the case has difficulty getting out of bed due to the progress of the disease or treatment factors. (3) Cases with difficulty in getting out of bed or at risk of falling due to the progress of the disease or treatment factors; (4) Cases using oxygen to walk for 6 minutes in the area of the oxygen nasal cannula and tubing; if there is a risk of falling or injury during the procedure, please stop all activities immediately and ask the caregiver to monitor the vital signs and notify the facilitator and home care provider. If the patient needs to be taken to the hospital for treatment, assist in contacting the ambulance and send to the nearest hospital or the hospital where the patient usually goes for treatment; the host will visit the hospital and understand the situation and fill in the abnormal events. Outcome measurement: The family, primary caregiver, and the case are instructed to correctly measure the number of laps, distance, time, and number of times to walk, and to give instructions. Outcome measures were collected by the co-facilitators at intake, month 1, month 2, month 3, and month 6, and all data and assessment scales were tracked.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • advanced cancer (cancer stage III or IV)
  • terminal ill disease
  • aged >=20 years
  • ECOG stage 0-3
  • Life expectancy =< 12 months

排除标准

  • unable to have normal conversation due to illness.

结局指标

主要结局

Steps count

时间窗: Change from Baseline at 6 month.

exercise outcome using pedometer

次要结局

  • Depression--Patient Health Questionnaire (PHQ-9)(Change from Baseline at 6 month.)
  • Quality of Life--EQ5D-5L(baseline and six month.)
  • Symptom Assessment---Chinese version of the Edmonton Symptom Assessment System,C-ESAS(Change from Baseline at 6 month.)
  • cancer fatigue--BFI(Change from Baseline at 6 month.)
  • Trial Outcome Index (TOI)(Change from Baseline at 6 month.)
  • Smart bracelet_Heart rate variability (HRV)(Continue wear bracelet five days to record HRV data.)

研究者

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

Tsai-Wei Huang

professor

Taipei Medical University

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