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

NCT05839743 | Completed

• 1 other identifier: 24032023
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Aerobic Exercise; Balance Exercise; Cognitive Function; Frailty; Reaction Time

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (3)

Aerobic Exercise Group

EXPERIMENTAL

Other: Aerobic Exercise

Balance Exercise Group

EXPERIMENTAL

Other: Balance Exercise

Combined Exercise Group

EXPERIMENTAL

Other: Combined Exercise

Interventions

Aerobic Exercise OTHER

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.

Aerobic Exercise Group

Balance Exercise OTHER

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.

Balance Exercise Group

Combined Exercise OTHER

In the combined exercise program, first balance exercises and then aerobic exercise program will be applied 2 days a week for 6 weeks.

Combined Exercise Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Ihlamur Konağı Nursing Home and Elderly Care Center

Ankara, Çankaya, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia; Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 3, 2023
• Study Start: May 30, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

TU (1)