NCT07418970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

January 12, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Action Observation TherapyBalanceExercise therapyFunctional capacity

Outcome Measures

Primary Outcomes (5)

  • Functional capacity

    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

    Baseline and 8 weeks

  • Dynamic balance performance

    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

    Baseline and 8 weeks

  • Static balance performance

    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

    Baseline and 8 weeks

  • Fatigue Level Assement

    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

    Baseline and 8 weeks

  • Cognitive function

    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.

    Baseline and 8 weeks

Study Arms (3)

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

Other: Action Observation Therapy

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.

Other: Action

Control Group

NO INTERVENTION

No action was taken.

Interventions

ActionOTHER

exercise

Exercise

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 program

Action Observation Therapy

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, 4400, Turkey (Türkiye)

Location

Related Publications (1)

  • No publications are currently available for this study.

    BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ilker Demir, PhD

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three parallel groups: a control group, an exercise group, or an action observation therapy group. Each group received its assigned intervention throughout the 8-week study period without crossover between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Doctor

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 18, 2026

Study Start

January 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 5, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations