NCT06520956

Brief Summary

The development of physical activity (PA) and exercise habits improves strength, flexibility, balance and coordination, activities such as walking, sleep quality and cognitive status in elderly people and supports their participation in social life. The aim of the study is to examine the effects of web-based Brain Breaks® (BB) video exercises (study group-WG) and posture and balance exercises (control group-CG) on the general physical condition, sleep quality and life satisfaction of elderly individuals. We expect this situation to improve the healthy lifestyle behaviors of elderly individuals. This study, planned to be conducted in two nursing homes, was planned as Evaluation-BB Physical Activity/Posture and Balance Exercises-Evaluation-1 month follow-up. Participants' sociodemographic characteristics, blood pressure, pulse, respiration, height, weight, muscle strength and flexibility, walking performance, posture, sleep and quality of life and life satisfaction will be evaluated. After the first evaluation, 2-3 BB video exercises will be applied to the study group (total n = 140 videos, t = 3-4 min) and posture and balance exercises (t = 20 min) to the control group, two days a week for 8 weeks, for a total of 16 sessions. During the follow-up period, physical activity habits will be questioned through weekly telephone calls (n = 4). All statistical analyzes will be performed in SPSS 26.0 program, and p value \<0.05 will be considered statistically significant. Differences within and between groups and relationships between data and factors affecting these data will be examined.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 20, 2024

Last Update Submit

July 20, 2024

Conditions

Keywords

Brain Breaks® (BB) videosphysical activityquality of lifewalkinghealth lifestyle

Outcome Measures

Primary Outcomes (1)

  • Six Minute Walking Test

    It is a test used to evaluate an individual's aerobic capacity. Individuals are asked to walk as much as possible for 6 minutes in a corridor that is at least 30 meters long and has a flat and hard surface. The distance traveled in 6 minutes is recorded. While the average walking distance is 570 meters for men aged 50-70 and 540 meters for women; It is stated as 530 meters for men aged 70-80 and 470 meters for women. Test results lower than these values may be associated with a decrease in aerobic capacity (American Thoracic Society 2002).

    At baseline and at week 8

Secondary Outcomes (6)

  • Posture Evaluation

    At baseline and at week 8

  • Healthy Lifestyle Behaviors Scale II

    At baseline and at week 8

  • Sleep quality

    At baseline and at week 8

  • Life Satisfaction Scale

    At baseline and at week 8

  • Flexibility assessment

    At baseline and at week 8

  • +1 more secondary outcomes

Study Arms (2)

Video-based exercise group

EXPERIMENTAL

In each session, 2 videos will be applied and each will be repeated 2-3 times, with a 3-minute rest break between each video. The total session will last an average of 20-30 minutes and 16 sessions of physical activity will be performed twice a week for a total of 8 weeks. A total of at least 140 GCH Brain Breaks® videos, each 3-4 minutes long, include aerobic exercises that include large joint movements, yoga and movements specific to different sports branches such as volleyball, basketball, football, tennis, karate, judo, warm-up and cool-down movements. includes national dances of different cultures

Behavioral: Video based exercise group

Control group

NO INTERVENTION

Any intervention will not be performed. After the initial evaluation, patients in this group will be given a single session of training on balance and posture exercises.

Interventions

In each session, 2 videos will be applied and each will be repeated 2-3 times, with a 3-minute rest break between each video. The total session will last an average of 20-30 minutes and 16 sessions of physical activity will be performed twice a week for a total of 8 weeks.

Video-based exercise group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older,
  • There is no health problem determined by the doctor that prevents physical activity,
  • Volunteering to participate in the study.

You may not qualify if:

  • Having a serious life-threatening chronic disease or dementia,
  • Having chronic or acute pain that prevents you from continuing to work,
  • Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Galata University

Istanbul, Beyoğlu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Habibe Serap Inal, Prof.Dr.

    Istanbul Galata University

    STUDY DIRECTOR
  • Gülenay Yıldırım, MsC

    Istanbul Galata University

    PRINCIPAL INVESTIGATOR
  • Büşra Ülker Ekşi, PhD(c)

    Istanbul Galata University

    STUDY CHAIR
  • Şafak Yiğit, PhD(c)

    Istanbul Galata University

    STUDY CHAIR
  • Nejla Uzun, PhD

    Istanbul Galata University

    STUDY CHAIR
  • Alihan Bilen, PhD(c)

    Istanbul Galata University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD(c)

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

July 18, 2024

Primary Completion

September 1, 2024

Study Completion

December 31, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations