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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839743
• Other study ID #: 24032023
• Status: Completed
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Exercise
• Cognitive Function
• Dementia
• Frailty
• Reaction Time

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ihlamur Konagi Nursing Home and Elderly Care Center	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Muscle Strength Assessment for Sarcopenia	Muscle strength measurement in kg with a dynamometer	Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Reaction Time Test	The 3 reaction times recorded in milliseconds are averaged.	Change from Baseline at 6 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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