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Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients

Primary Purpose

Dementia, Aerobic Exercise, Balance Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Balance Exercise
Combined Exercise
Sponsored by
Yuksek Ihtisas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 65 years, To be able to speak and understand Turkish, To have at least primary education, Perceive and adapt to simple commands, Scoring between 18-23 on the standardized mini mental state assessment scale (200), To be able to provide independent mobilization, Volunteering to participate. Exclusion Criteria: Rapid progression of dementia (infectious, vascular, hematologic diseases), Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period, Presence of malignancy, Detection of a delirium picture, Presence of severe depression, Participate in a regular exercise program for at least 6 months before the study, Having a fracture or fracture surgery in the lower extremity within the last year, Any orthopedic problem that prevents him/her from exercising.

Sites / Locations

  • Ihlamur Konağı Nursing Home and Elderly Care Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Aerobic Exercise Group

Balance Exercise Group

Combined Exercise Group

Arm Description

Outcomes

Primary Outcome Measures

Edmonton Frailty Scale
0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty
Muscle Strength Assessment for Sarcopenia
Muscle strength measurement in kg with a dynamometer
30 Seconds Sit To Stand Test
For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.
Single Leg Stance Test
If unable to stand for 5 seconds or less client at greater risk of injury from fall.
Tinetti Balance and Gait Assessment
The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Dynamic Gait Index
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the Dynamic Gait Index is a 24.
Functional Reach Test
10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.
Johns Hopkins Fall Risk Assessment Tool
6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk
Reaction Time Test
The 3 reaction times recorded in milliseconds are averaged.
Mini Mental State Examination
The maximum score for the Mini Mental State Examination is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
The World Health Organization Quality of Life - Old Module
It is scored in the range of 4-20. The higher the score, the better the quality of life.
Geriatric Depression Scale
There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.
Wechsler Memory Scale
Scored on 1-19 Scaled Score Metric. High scores (13 and above) indicate better than expected performance on the dependent variable given performance on the control variable. Low scores (7 and below) indicate poorer than expected performance on the dependent score given performance on the control score. Scores in the average range (8-12) indicate no difference in performance between the control and dependent measures.
Mental Rotation Test
Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.
Spatial Orientation Test
Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
September 27, 2023
Sponsor
Yuksek Ihtisas University
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1. Study Identification

Unique Protocol Identification Number
NCT05839743
Brief Title
Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients
Official Title
Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuksek Ihtisas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. The methods used today are symptomatic and cause various side effects. For this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. Among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. There are also many studies showing that dementia is directly related to physical performance and frailty. Deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. In addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. In order to prevent the risk of falls, exercise practices are of great importance. Although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. In addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. Therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Aerobic Exercise, Balance Exercise, Cognitive Function, Frailty, Reaction Time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Group
Arm Type
Experimental
Arm Title
Balance Exercise Group
Arm Type
Experimental
Arm Title
Combined Exercise Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
The aerobic exercise program will be specially prepared for the participants and will aim to rhythmically exercise large muscle groups. The exercise will be performed twice a week for 6 weeks at 50-75% of maximum heart rate for 20-50 minutes per session. Each exercise will last 30-60 minutes in total, after adding 5 minutes of warm-up and 5 minutes of cool-down before and after the exercise. The participant's pulse will be monitored continuously during the exercise.
Intervention Type
Other
Intervention Name(s)
Balance Exercise
Intervention Description
Balance exercises belonging to the Otago Exercise Program and other balance exercises used in the elderly will be prepared specifically for the participant and will be applied 2 days a week for 6 weeks in combination. Before and after the exercise, a 5-minute warm-up and 5-minute cool-down exercise will be performed.
Intervention Type
Other
Intervention Name(s)
Combined Exercise
Intervention Description
In the combined exercise program, first balance exercises and then aerobic exercise program will be applied 2 days a week for 6 weeks.
Primary Outcome Measure Information:
Title
Edmonton Frailty Scale
Description
0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty
Time Frame
Change from Baseline Edmonton Frailty Scale at 6 weeks
Title
Muscle Strength Assessment for Sarcopenia
Description
Muscle strength measurement in kg with a dynamometer
Time Frame
Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks
Title
30 Seconds Sit To Stand Test
Description
For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.
Time Frame
Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks
Title
Single Leg Stance Test
Description
If unable to stand for 5 seconds or less client at greater risk of injury from fall.
Time Frame
Change from Baseline Single Leg Stance Test at 6 weeks
Title
Tinetti Balance and Gait Assessment
Description
The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Time Frame
Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks
Title
Dynamic Gait Index
Description
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the Dynamic Gait Index is a 24.
Time Frame
Change from Baseline Dynamic Gait Index at 6 weeks
Title
Functional Reach Test
Description
10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.
Time Frame
Change from Baseline Functional Reach Test at 6 weeks
Title
Johns Hopkins Fall Risk Assessment Tool
Description
6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk
Time Frame
Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks
Title
Reaction Time Test
Description
The 3 reaction times recorded in milliseconds are averaged.
Time Frame
Change from Baseline at 6 weeks
Title
Mini Mental State Examination
Description
The maximum score for the Mini Mental State Examination is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Time Frame
Change from Baseline Reaction Time Test at 6 weeks
Title
The World Health Organization Quality of Life - Old Module
Description
It is scored in the range of 4-20. The higher the score, the better the quality of life.
Time Frame
Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks
Title
Geriatric Depression Scale
Description
There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.
Time Frame
Change from Baseline Geriatric Depression Scale at 6 weeks
Title
Wechsler Memory Scale
Description
Scored on 1-19 Scaled Score Metric. High scores (13 and above) indicate better than expected performance on the dependent variable given performance on the control variable. Low scores (7 and below) indicate poorer than expected performance on the dependent score given performance on the control score. Scores in the average range (8-12) indicate no difference in performance between the control and dependent measures.
Time Frame
Change from Baseline Wechsler Memory Scale at 6 weeks
Title
Mental Rotation Test
Description
Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.
Time Frame
Change from Baseline Mental Rotation Test at 6 weeks
Title
Spatial Orientation Test
Description
Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.
Time Frame
Change from Baseline Spatial Orientation Test at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 65 years, To be able to speak and understand Turkish, To have at least primary education, Perceive and adapt to simple commands, Scoring between 18-23 on the standardized mini mental state assessment scale (200), To be able to provide independent mobilization, Volunteering to participate. Exclusion Criteria: Rapid progression of dementia (infectious, vascular, hematologic diseases), Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period, Presence of malignancy, Detection of a delirium picture, Presence of severe depression, Participate in a regular exercise program for at least 6 months before the study, Having a fracture or fracture surgery in the lower extremity within the last year, Any orthopedic problem that prevents him/her from exercising.
Facility Information:
Facility Name
Ihlamur Konağı Nursing Home and Elderly Care Center
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06810
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients

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