跳至主要内容
临床试验/NCT05603533
NCT05603533招募中不适用

The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia

Hasselt University8 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
8
主要终点
The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using the modified timed chair stand test.

研究概览

简要总结

The aim of this study is to asses the effect of a music and video-based group exercise therapy on motivation, physical functioning, cognition and well-being in older adults with moderate dementia.

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)

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

  • Men and women with moderate dementia (MMSE between 12 and 20)
  • Age 65 years or older
  • Resident in nursing home for at least 30 days
  • Able to stand (supported) for 10 seconds with supervision

排除标准

  • Inadequate functional hearing
  • Uncorrected visual problems
  • Rehabilitating from an orthopedic or neurologic insult
  • Known disability that significantly influences 6 month prognosis

结局指标

主要结局

The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using the modified timed chair stand test.

时间窗: At baseline, after 2 and 4 months

The timed chair stand test is a valid and reliable test to evaluate muscle strength in older adults. The participant will be asked to stand up and sit back down on a chair five times without using their hands. The time it takes to perform this task will be measured.

The change in compliance between 1,2,3 and 4 months into the intervention will be measured

时间窗: 1,2,3 and 4 months of intervention

Compliance will be measured by assessing whether the participants exercised at the prescribed intensity. To evaluate compliance, two exercises sessions will be recorded and results will be averaged to compensate for daily fluctuations. Both quality and quantity of the participants' performances will be scored. To measure the quantity, the amount of repetitions the participant performed will be rated from zero (no repetitions) to three (all repetitions). A score of two was chosen as cut-off score, indicating that more than half of the exercises were performed. To measure quality, the recorded performances will be compared with the visual instructions on the TV-screen and will be scored on a scale from zero (no repetitions) to three (the performance matched completely with the instructions). A score of two was chosen as cut-off score, indicating that more than half of the exercises were matched with the instructions.

Attrition rate

时间窗: Twice a week for 4 months

The amount of participants that discontinued the program

The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using a hand-held dynamometer

时间窗: At baseline, after 2 and 4 months

When using the hand-held dynamometer to measure strength, the break technique will be used. The examiner will apply resistance in a fixed position and the person being tested exerts a maximum effort against the dynamometer for 3-5 seconds. At the last second, the examiner applies a resistance sufficient to overcome the maximum effort of the person being tested and cause the subject's joint to move.

The change in adherence between 1,2,3 and 4 months into the intervention will be measured

时间窗: 1,2,3 and 4 months of intervention

Adherence will be measured by counting the amount of therapy sessions each participant completed (%)

The change in motivation between 1,2,3 and 4 months into the intervention will be measured using the observed emotion rating scale (OERS)

时间窗: 1,2,3 and 4 months of intervention

The OERS evaluates the positive (pleasure, interest/alertness) and negative mood (anger, anxiety, sadness) by observing the extent or duration of facial expressions and body movements and has a moderate to high interrater reliability. To evaluate the OERS, two exercise sessions will be recorded each month and results will be averaged to compensate for daily fluctuations.

次要结局

  • The change in activity level and sleep between baseline, mid-intervention and at the end of intervention will be measured using an Actigraph(At baseline, after 2 and 4 months)
  • The change in cognition between baseline, mid-intervention and at the end of intervention will be assessed using the Montreal Cognitive Assessment (MOCA)(At baseline, after 2 and 4 months)
  • The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test(At baseline, after 2 and 4 months)
  • The change in quality of life between baseline, mid-intervention and at the end of intervention will be assessed using the ICEpop CAPability measure for Older people (ICECAP-O)(At baseline, after 2 and 4 months)
  • The change in behavioral and psychological symptoms of dementia between baseline, mid-intervention and at the end of intervention will be evaluated using the Dutch version of the Cohen-Mansfield Agitation Inventory (CMAI-D)(At baseline, after 2 and 4 months)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tinne Plattiau

Msc

Hasselt University

研究点 (8)

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