跳至主要内容
临床试验/NCT05825989
NCT05825989招募中不适用

The Effects of Healthy Beat Acupunch on Physical Fitness of Thai Older Adults in Residential Homes

Kaohsiung Medical University4 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
92
试验地点
4
主要终点
Physical fitness: handgrip strength

研究概览

简要总结

The purpose of this study is to test the effects of the first three months of instructor-led HBA regimen on physical fitness (aerobic endurance, lung capacity, upper body flexibility, lower body flexibility, handgrip strength, upper body strength, and lower body strength) between the HBA intervention and control groups, to test the effects of another three months of DVD-led HBA regimen followed by the three months of instructor-led on physical fitness between the HBA intervention and control groups and to test the changes at three and six months of the HBA regimen in comparison to the baseline of the physical fitness in the HBA intervention group.

详细描述

After the researcher meet the potential participants regarding the inclusion criteria, the researcher will inform purpose of study, human subjects protection, and termination in this study. Once participants receive all information and need to participate in this study, the researcher will ask permission participants to sign in their names in the informed consent and participant information sheet. If participants cannot sign their names, a thumbprint will be used instead of signatures. Therefore, the consent form will be completed by signatures or thumbprints.

This study will conduct in group exercise. The intervention group will receive the HBA program, 40 min/time, 3 times/week for 6 months. The control group will continue their routine activities of the residential homes.

研究设计

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

入排标准

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

入选标准

  • Mild to moderate dependence or complete independence as defined by an Activity Daily Living assessment using the Barthel Index (BI Thai version) with a score of 61 or higher
  • No cognitive impairment defined by a Short Portable Mental Status Questionnaire (SPMSQ Thai version) a score of ≥ 8
  • No experience with the HBA regimen
  • Able to communicate in Thai

排除标准

  • Older adults whom physicians have advised not to exercise because of medical conditions, severe disease, such as severe cardiopulmonary disease (CVD, COPD), or severe musculoskeletal diseases, and have sensory impairments such as visual and auditory impairments.

结局指标

主要结局

Physical fitness: handgrip strength

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded.

Physical fitness: aerobic endurance

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded.

Physical fitness: upper body flexibility

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score.

Physical fitness: upper body strength

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded.

Physical fitness: lower body flexibility

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score.

Physical fitness: lung capacity

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters.

Physical fitness: lower body strength

时间窗: posttest 2 (after receiving the HBA regimen at 6 months)

Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded.

次要结局

未报告次要终点

研究者

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

Siriluk Winitchayothin, RN

The Effects of Healthy Beat Acupunch on Physical Fitness of Thai Older Adults in Residential Homes

Kaohsiung Medical University

研究点 (4)

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