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

Sponsor
Yuksek Ihtisas University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05839743
Collaborator
(none)
33
3
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic Exercise
  • Other: Balance Exercise
  • Other: Combined Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Edmonton Frailty Scale [Change from Baseline Edmonton Frailty Scale at 6 weeks]

    0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty

  2. Muscle Strength Assessment for Sarcopenia [Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks]

    Muscle strength measurement in kg with a dynamometer

  3. 30 Seconds Sit To Stand Test [Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks]

    For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.

  4. Single Leg Stance Test [Change from Baseline Single Leg Stance Test at 6 weeks]

    If unable to stand for 5 seconds or less client at greater risk of injury from fall.

  5. Tinetti Balance and Gait Assessment [Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks]

    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.

  6. Dynamic Gait Index [Change from Baseline Dynamic Gait Index at 6 weeks]

    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.

  7. Functional Reach Test [Change from Baseline Functional Reach Test at 6 weeks]

    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.

  8. Johns Hopkins Fall Risk Assessment Tool [Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks]

    6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk

  9. Reaction Time Test [Change from Baseline at 6 weeks]

    The 3 reaction times recorded in milliseconds are averaged.

  10. Mini Mental State Examination [Change from Baseline Reaction Time Test at 6 weeks]

    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.

  11. The World Health Organization Quality of Life - Old Module [Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks]

    It is scored in the range of 4-20. The higher the score, the better the quality of life.

  12. Geriatric Depression Scale [Change from Baseline Geriatric Depression Scale at 6 weeks]

    There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.

  13. Wechsler Memory Scale [Change from Baseline Wechsler Memory Scale at 6 weeks]

    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.

  14. Mental Rotation Test [Change from Baseline Mental Rotation Test at 6 weeks]

    Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.

  15. Spatial Orientation Test [Change from Baseline Spatial Orientation Test at 6 weeks]

    Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yuksek Ihtisas University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ilkem Guzel, Lecturer, Yuksek Ihtisas University
ClinicalTrials.gov Identifier:
NCT05839743
Other Study ID Numbers:
  • 24032023
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023