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临床试验/NCT03748797
NCT03748797已完成不适用

Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong

The Society for AIDS Care1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Change of SF-36 scores

研究概览

简要总结

The effects of exercise for older HIV-infected adults have not been well studied, especially in Chinese population. This study aimed to investigate the effect of supervised exercise on physical health and quality of life among older people living with HIV (PLWH) in Hong Kong.

HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services. Participants were randomized into exercise group or control group. The participants in exercise group performed an 8-week moderate intensity supervised exercise program. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises.

Outcomes were measured for both groups at baseline and after 8 weeks. Primary outcomes: grip strength, 30 seconds chair stand, 6 minutes-walk test and Short Form-36 questionnaire (SF-36). Secondary outcome: Subjective improvement

At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.

详细描述

It is a randomized controlled trial. HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services.They were randomized into exercise group or control group by drawing lots which contained equal number of orange balls (exercise) and white balls (control)

The participants in exercise group performed an 8-week, 2 times/week supervised exercise program in the community day center of the recruiting NGO. Exercise sessions were organized in a group of 2 to 3 participants. The exercises were supervised by a registered physiotherapist to ensure exercise safety and quality. Exercise intensity was moderate. We monitored the heart rate of participants during exercise and maintained around 50% to 70% of maximum heart rate. Blood pressure and oxygen saturation were also checked for safety purposes. The mode of exercise was combined aerobic and resistance training. It involved upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise. The duration for each exercise session was around 45 minutes. Duration and intensity of exercises were adjusted depending on the tolerance and physical capacity of each participant. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises. Control group participants were allowed to join into the same training program after the research had finished.

Outcomes were measured for both groups at baseline and after 8 weeks in the same community day center. A research assistant who was blinded for the participants grouping was responsible for data collection. Physical health parameters included grip strength, 30 seconds chair stand and 6 minutes-walk test. Health related quality of life was measured by Short Form-36 questionnaire (SF-36). Subjective improvement was taken in form of Likert scale, from -100% to +100% with 10% interval in each possible response.

At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

A research assistant who was blinded for the participants grouping was responsible for data collection.

入排标准

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

入选标准

  • Participants with HIV age > 50, treating with antiretroviral therapy
  • No contraindication to moderate intensity exercise
  • Independent Outdoor walker without assistance
  • Sedentry participants who have not received any structural / supervised exercise program in the past 1 year

排除标准

  • Unstable or unfit for exercise
  • Wheelchair user or assisted walker
  • Already had regular exercise habit or under structural exercise program in the past 1 year

研究组 & 干预措施

Control group

No Intervention

No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have

Exercise group

Experimental

8-week moderate intensity exercise training under supervision

干预措施: Moderate intensity exercise training under supervision (Other)

结局指标

主要结局

Change of SF-36 scores

时间窗: Change from Baseline SF-36 scores at 8 weeks

Short Form 36 (SF-36) questionnaire is used to assess health related quality of life

Change of Grip strength

时间窗: Change from Baseline grip strength at 8 weeks

Maximum grip strength of the participant in kg

Change of 30 seconds chair stand

时间窗: Change from Baseline performance at 8 weeks

Number of times that the participant stand up and sit down within 30 seconds

Change of 6 minutes walk test

时间窗: Change from Baseline performance at 8 weeks

The distance (in meters) which the participant is able to walk in 6 minutes

次要结局

  • Subjective improvement(Subjective change after 8 weeks compare to baseline)

研究者

发起方
The Society for AIDS Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi Hong, CHUNG

Physiotherapist

The Society for AIDS Care

研究点 (1)

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