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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Frailty; Cognitive Function; Reaction Time; Aerobic Exercise; Balance Exercise
• Intervention / Treatment: Other: Aerobic Exercise; Other: Balance Exercise; Other: Combined Exercise

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06810
      • Ihlamur Konağı Nursing Home and Elderly Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise Group	Other: Aerobic Exercise; 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.
Experimental: Balance Exercise Group	Other: Balance Exercise; 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.
Experimental: Combined Exercise Group	Other: Combined Exercise; In the combined exercise program, first balance exercises and then aerobic exercise program will be applied 2 days a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edmonton Frailty Scale	0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty	Change from Baseline Edmonton Frailty Scale at 6 weeks
Muscle Strength Assessment for Sarcopenia	Muscle strength measurement in kg with a dynamometer	Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks
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.	Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks
Single Leg Stance Test	If unable to stand for 5 seconds or less client at greater risk of injury from fall.	Change from Baseline Single Leg Stance Test at 6 weeks
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.	Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks
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.	Change from Baseline Dynamic Gait Index at 6 weeks
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.	Change from Baseline Functional Reach Test at 6 weeks
Johns Hopkins Fall Risk Assessment Tool	6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk	Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks
Reaction Time Test	The 3 reaction times recorded in milliseconds are averaged.	Change from Baseline at 6 weeks
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.	Change from Baseline Reaction Time Test at 6 weeks
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.	Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks
Geriatric Depression Scale	There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.	Change from Baseline Geriatric Depression Scale at 6 weeks
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.	Change from Baseline Wechsler Memory Scale at 6 weeks
Mental Rotation Test	Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.	Change from Baseline Mental Rotation Test at 6 weeks
Spatial Orientation Test	Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.	Change from Baseline Spatial Orientation Test at 6 weeks

Collaborators and Investigators

• Sponsor: Yuksek Ihtisas University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 29, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Frailty
• Other Study ID Numbers: 24032023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No