- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07823166
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait in Geriatric Individuals Residing in Nursing Homes: A Randomized Controlled Trial
This study aimed to compare the effects of motor and cognitive dual-task exercise programs on fall risk, balance, and gait performance in older adults residing in nursing homes.The main question it aims to answer is:
An eight-week motor or cognitive dual-task exercise program did not provide additional benefits over standard single-task exercise in improving fall risk, balance, or gait performance in nursing home residents.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Assessments were conducted before and after the intervention using the Five-Repetition Sit-to-Stand Test, 2-Minute Walk Test, Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Scale, and Functional Reach Test.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals residing in nursing homes who were aged between 65 and 95 years, able to walk independently, literate, willing to participate, and cognitively capable of understanding and performing the assessments and exercises were included in the study.
Individuals with systemic or metabolic conditions such as malignancy, osteoporosis, history of fracture, coagulation disorders, active infection, orthostatic hypotension, or pacemaker implantation were excluded. Participants were withdrawn from the study if they discontinued the intervention, failed to attend pre- or post-intervention assessments, or were unable to understand or perform the required tests and exercises.
A total of 69 eligible participants were allocated into three groups using a systematic allocation sequence based on the order of enrollment. Participants were assigned sequentially to the motor dual-task group, cognitive dual-task group, or control group in a 1:1:1 ratio.
Due to the absence of a dedicated exercise room, all interventions were conducted in participants' rooms using space-adapted exercise protocols.
Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task. During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Baseline demographic characteristics, including participant identification number, group allocation, age, sex, body weight, and height, were recorded using a standardized assessment form. All evaluations were performed before and after the eight-week intervention period by the same physiotherapist to ensure assessment consistency and minimize inter-rater variability.
Fall risk was assessed using the Five Times Sit-to-Stand Test (FTSST). Balance and gait performance were evaluated using the 2-Minute Walk Test (2MWT), Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Assessment Scale, and Functional Reach Test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ÇANKAYA
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Ankara, ÇANKAYA, Turkey (Türkiye), 06550
- Altınçatı Nursing Home and Elderly Care Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- residing in nursing homes who were aged between 65 and 95 years
- Individuals able to walk independently
- Individuals who are literate
- Individuals willing to participate in the study
- Individuals cognitively capable of understanding and performing the required assessments and exercises.
Exclusion Criteria:
- Individuals with malignancy
- Individuals with osteoporosis
- Individuals with a history of fracture
- Individuals with coagulation disorders
- Individuals with an active infection
- Individuals with orthostatic hypotension
- Individuals with pacemaker implantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
|
Experimental: Motor Dual-Task Exercise Group
|
Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
|
Experimental: Cognitive Dual-Task Exercise Group
|
Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task.
During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-Minute Walk Test (2MWT)
Time Frame: 8 weeks
|
Walking capacity was assessed over a 30-meter walkway during a two-minute period.
Participants wore comfortable clothing and footwear and rested for 10 minutes before testing.
The total walking distance was recorded in meters.
|
8 weeks
|
|
Five Times Sit-to-Stand Test (FTSST)
Time Frame: 8 weeks
|
The FTSST was used to assess lower extremity strength, functional mobility, and fall risk.
Participants were instructed to stand up from a standard chair and sit down five consecutive times as quickly as possible while keeping their arms crossed over the chest.
Total completion time was recorded using a stopwatch.
|
8 weeks
|
|
Timed Up and Go (TUG) Test
Time Frame: 8 weeks
|
Functional mobility was assessed by measuring the time required for participants to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down.
Time was recorded in seconds using a stopwatch.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-Leg Stance Test
Time Frame: 8 weeks
|
Static balance was evaluated by asking participants to stand on one leg while lifting the opposite foot approximately 5 cm off the ground.
Participants were instructed to maintain balance for as long as possible, and the duration was recorded using a stopwatch.
|
8 weeks
|
|
Tinetti Balance and Gait Assessment Scale
Time Frame: 8 weeks
|
Balance and gait performance were assessed using the Tinetti Balance and Gait Assessment Scale according to standardized administration procedures.
Total scores were used to classify fall risk.
|
8 weeks
|
|
Functional Reach Test
Time Frame: 8 weeks
|
Dynamic balance was assessed using the Functional Reach Test.
A measuring tape was positioned horizontally on the wall at shoulder height.
Participants were instructed to reach forward as far as possible with the dominant arm elevated to 90° shoulder flexion without stepping or losing balance.
The distance between the initial and maximal reach positions was recorded in centimeters.
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: BİHTER AKINOĞLU, Assoc. Prof. Dr., PT., Ankara Yildirim Beyazıt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBU-FTR-BA-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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