NCT03878394

Brief Summary

Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. For this reason, the aim of this is to investigate the effects of different home exercise programs on cognitive function, balance and daily living activities in healthy individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

February 11, 2022

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

March 15, 2019

Last Update Submit

January 28, 2022

Conditions

Keywords

balancecognitive functionhealthy individualsquality of lifecognitive exercisesdepression

Outcome Measures

Primary Outcomes (3)

  • Montreal Cognitive Assessment (MOCA)

    Montreal Cognitive Assessment (MOCA) was developed by Nasreddine et al. to distinguish healthy individuals from individuals with mild cognitive impairment. MOCA evaluates 8 different functions including attention and concentration, executive functions, memory, language, visual-spatial skills, calculation and orientation and abstract thinking. The highest score is 30. 21 points and above are considered normal.

    6 weeks

  • Stroop Test

    The Stroop Test measures the speed of information processing, the ability to suppress a customary behavior, focused attention, the ability to perform an unusual behavior, and the ability to change perceptual setup under varying demands and under a disturbing effect. The standardization studies of Stroop Test in our country were performed by Karakaş et al. The Turkish form was named Stroop Test TBAG Form. The Stroop Test TBAG Form consists of four white cards. Each card has 6 rows sorted randomly and 4 items per line. These cards contain the stimulants of the test.

    6 weeks

  • Benton Face Recognition Test

    The face recognition test was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately.

    6 weeks

Secondary Outcomes (6)

  • Berg Balance Test

    6 weeks

  • 6 Minute Walk Test

    6 weeks

  • Geriatric Depression Scale

    6 weeks

  • Short Form 36 Quality of Life Questionnaire (SF-36)

    6 weeks

  • Time up and Go Test

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.

Other: aerobic exercise and balance exercises

Group 2

EXPERIMENTAL

The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.

Other: aerobic exercise and balance exercisesOther: aerobic exercise and balance exercises with cognitive exercises

Interventions

The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.

Group 1Group 2

The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.

Group 2

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants between the ages of 60 and 80
  • Mini Mental Status Test score to be over 24

You may not qualify if:

  • Cardiovascular disease
  • Cardiovascular surgery operation, pacemaker etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Beykoz, Istanbul, 34810_, Turkey (Türkiye)

Location

Related Publications (3)

  • Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.

    PMID: 20101012BACKGROUND
  • Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.

    PMID: 22529236BACKGROUND
  • Paterson DH, Warburton DE. Physical activity and functional limitations in older adults: a systematic review related to Canada's Physical Activity Guidelines. Int J Behav Nutr Phys Act. 2010 May 11;7:38. doi: 10.1186/1479-5868-7-38.

    PMID: 20459782BACKGROUND

Related Links

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miray Budak, assoc.prof.

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

March 18, 2019

Primary Completion

January 27, 2020

Study Completion

February 3, 2020

Last Updated

February 11, 2022

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations