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临床试验/NCT07418970
NCT07418970已完成不适用

Investigating the Effects of Action Observation Therapy on Cognitive Function, Balance, Fatigue, and Functional Capacity in Geriatric Individuals: A Randomized Controlled Trial

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年1月1日最近更新:
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
162
试验地点
1
主要终点
Functional capacity

研究概览

简要总结

This randomized controlled trial aimed to investigate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals. Participants aged 65 years and older were randomly assigned to one of three groups: a control group, an exercise group, or an action observation therapy group. The intervention period lasted 8 weeks. The exercise group received a conventional exercise program, while the action observation therapy group watched exercise videos before performing the same exercises. The control group did not participate in any structured exercise program during the study period. Outcome measures included cognitive function, balance performance, fatigue levels, and functional capacity. The study evaluated whether adding action observation therapy to conventional exercise provides additional benefits in older adults.

详细描述

This study is a three-arm randomized controlled trial designed to evaluate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals aged 65 years and older.

Participants were randomly assigned to one of three groups: (1) a control group that did not receive any structured exercise intervention during the study period, (2) an exercise group that participated in a conventional exercise program, and (3) an action observation therapy group that watched exercise demonstration videos prior to performing the same conventional exercise program.

The intervention period lasted 8 weeks. The conventional exercise program included balance, strengthening, and functional mobility exercises appropriate for older adults. The action observation therapy group observed standardized exercise videos to facilitate motor learning before actively performing the exercises.

Primary and secondary outcome measures included cognitive function (e.g., Montreal Cognitive Assessment), balance performance (e.g., Timed Up and Go Test and One-Leg Stand Test), fatigue levels (e.g., Fatigue Severity Scale), and functional capacity (e.g., 6-Minute Walk Test). Assessments were performed at baseline and at the end of the 8-week intervention period.

The primary objective of the study was to determine whether adding action observation therapy to conventional exercise provides additional benefits in cognitive and functional outcomes in geriatric individuals.

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
None

盲法说明

This study was conducted as an open-label trial. Participants and researchers were aware of group assignments due to the nature of the exercise and action observation interventions. No blinding was applied.

入排标准

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

入选标准

  • Aged 65 years and older
  • Community-dwelling older adults
  • Able to ambulate independently with or without an assistive device
  • Able to understand and follow verbal instructions
  • Provided written informed consent

排除标准

  • Severe neurological, vestibular, or orthopedic conditions affecting balance or mobility
  • Severe visual or hearing impairment interfering with participation
  • Diagnosed psychiatric disorders affecting cognitive assessment
  • Participation in another structured exercise program during the study period
  • Any medical condition contraindicating exercise participation

研究组 & 干预措施

Action Observation Therapy

Experimental

Based on exercise recommendations for older adults from the American College of Sports Medicine (ACSM), the researcher developed a conventional exercise training programme suitable for participants aged 65 and over, incorporating balance, strength and flexibility exercises. In parallel, an action observation therapy exercise video recording was prepared for the experimental group participants. The exercises were easy to learn, not complex in terms of memory and performance, performed standing up without sitting down, and progressed from easy to difficult.

The exercise programme was carried out for a total of 16 sessions over four weeks, with 8 repetitions per set for the first four weeks and 12 repetitions per set for the next four weeks, for 30-45 minutes, twice a week.

Participants in the control group were informed that they would be enrolled in their preferred exercise programme afterwards, and no exercise programme was implemented throughout the study. The same exercise progra

干预措施: Action Observation Therapy (Other)

Exercise

Active Comparator

Warm-up Exercises: Active joint range of motion and sequential circumduction of the shoulder forwards and backwards,

  • Weight transfer to the hips in a seated position,
  • Isometric contraction exercises for the lower extremity extensor, flexor, adductor, and abductor groups in a seated position (performed using a towel or thin pillow),
  • Bridge pose,
  • Hip abduction in a side-lying position,
  • Knee and shoulder flexion and extension,
  • Supine position trunk flexion,
  • Weight transfer to lower extremities while standing,
  • Semi squat,
  • Walking,
  • Cool-down Exercises: Performed as stretching and breathing exercises for the hamstrings, quadriceps femoris, and pectoral muscles.

The exercises consisted of these movements.

干预措施: Action (Other)

Control Group

No Intervention

No action was taken.

结局指标

主要结局

Functional capacity

时间窗: Baseline and 8 weeks

To determine functional capacity, the 6-Minute Walk Test (6MWT) was administered in accordance with the American Thoracic Society protocol. During the test, patients were expected to complete the test by walking as fast as possible on a 30-metre straight corridor without running. Before starting, individuals were informed about the test and verbally advised that they could slow down, rest, and terminate the test if they felt tired or short of breath. The 6MWT test was interpreted according to gender using the following formulas

Dynamic balance performance

时间窗: Baseline and 8 weeks

During the test, the time it took for the patient to get up from the chair they were sitting in, walk a distance of 3 meters, then return to the starting position was measured

Static balance performance

时间窗: Baseline and 8 weeks

The test was performed to measure static standing capacity. The time was started when the person lifted their foot and stopped when the lifted foot touched the ground, the supporting foot bounced, or the person had to take support to maintain balance. It was performed twice with eyes open, and the average time was recorded

Fatigue Level Assement

时间窗: Baseline and 8 weeks

Fatigue severity scale was applied to evaluate the fatigue levels of the patients. This scale consists of a total of 9 questions, and each question was scored from one to seven depending on the participants' agreement with the questions. The scores on the scale are 1 point for strongly disagree, 3 points for tend to disagree, 4 points for undecided, 5 points for tend to agree, and 7 points for strongly agree

Cognitive function

时间窗: Baseline and 8 weeks

Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates global cognitive performance including attention, memory, language, executive functions, and visuospatial abilities in older adults.

次要结局

未报告次要终点

研究者

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

İlker DEMİR

PHD Doctor

Hasan Kalyoncu University

研究点 (1)

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