ClinicalTrials.gg
Status unknownNCT06520956Updated Jul 25, 2024

Improving the Quality of Life of Elderly Individuals Living in Nursing Homes

An interventional study of Video based exercise group in Elderly People, sponsored by Istanbul Galata University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Istanbul Galata University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 995 studies in Motor Activity with a site in Turkey — 196 open to participants now, 225 under way, none of them phase 3. Motor Activity · Turkey.

Enrollment
291st of 768
50 · median 42
Started
2024
with 147 others
No phase
768 of 995
160 open now
Registered
574th of 995
by date

Among the 995 studies in Motor Activity with a site in Turkey, this one is the 291st largest by enrollment of the 768 interventional ones that give a count, is one of 148 that started in 2024, is one of 768 with no phase, and was the 574th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

196 of the 995 studies in Motor Activity with a site in Turkey are open now. Recruiting first, the newest first:

191 more — sign in →

All 196 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 65 Years to 85 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Elderly People

Browse trials for

Keywords

  • Brain Breaks® (BB) videos
  • physical activity
  • quality of life
  • walking
  • health lifestyle
04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Video-based exercise group

    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

  • No intervention
    Control group

    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

  • BehavioralVideo based exercise group

    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.

06

What researchers measure

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).

    Time frame: At baseline and at week 8

Secondary outcomes

  1. Posture Evaluation

    People's postures were evaluated with the New York Posture Assessment Test on thirteen (13) parts of the body from the back (head-A, shoulder levels-B, vertebral column-C, hip levels-D, mediolateral position of the feet-E, foot arches-F) and side ( head-G, rib cage-H, shoulders-I, upper back-J, trunk-K, abdomen-L, lower back-waist-M) will be observed and scored on the form. Accordingly, five (5) points will be given if the posture of the examined area is good, three (3) points will be given if it is moderately damaged, and one (1) point will be given if it is seriously damaged. The total score obtained as a result of the test is a maximum of 65 and a minimum of 13. Accordingly, if the score is 45, it will be classified as 'very good', if it is between 40-44, it will be classified as 'good', if it is 30-39, it will be classified as 'medium', if it is 20-29, it will be classified as poor and if it is 19, it will be classified as 'bad'.

    Time frame: At baseline and at week 8

  2. Healthy Lifestyle Behaviors Scale II

    The Healthy Lifestyle Behaviors Scale, developed by Walker et al. (1987), was revised in 1996 and named Healthy Lifestyle Behaviors Scale II. The alpha value of the scale, which has a total of 52 items and 6 sub-factors (health responsibility, physical activity, nutrition, spiritual development, interpersonal relations, stress management), was determined as 0.94. A high total score indicates that there are more healthy lifestyle behaviors (Bahar et al., 2008).

    Time frame: At baseline and at week 8

  3. Sleep quality

    Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PSQI), developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). PSQI is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month. It consists of 24 questions. 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleeping Medication Use, and Daytime Dysfunction. Each component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the total score of the scale. Total score varies between 0-21. A total score greater than 5 indicates "poor sleep quality".

    Time frame: At baseline and at week 8

  4. Life Satisfaction Scale

    To evaluate life satisfaction, the Content with Life Scale, consisting of 5 items developed by Lavallee et al. (2007), will be used (27). This one-dimensional scale has a 7-point Likert-type rating ("1" strongly disagree - "7" strongly agree). Turkish validity and reliability analysis was conducted by Akın and Yalnız (2015), and high scores indicate a high level of life satisfaction.

    Time frame: At baseline and at week 8

  5. Flexibility assessment

    For Shortness-Flexibility evaluation, shoulder (Apley test) and lower extremity flexibility (sit-reach test) (short:3, moderately short:2 and normal:1) will be tested. Measurements will be taken separately for the right and left side of the body.

    Time frame: At baseline and at week 8

  6. Barthel Index

    The index developed by Mahoney and Barthel in 1965 was modified by Shah et al. (1992). This scale evaluates mobility status and stair climbing functions such as feeding, washing, self-care, dressing, defecation control, urinary control, going to the toilet, ability to move from bed to wheelchair, walking or being dependent on a wheelchair, and stair climbing on a scale of 5-15 points (depending on the question). It consists of a total of 10 items that grade each other (0-15 points in 5-point increments).

    Time frame: At baseline and at week 8

07

Study locations

1 site
  • Istanbul Galata University
    Istanbul, Beyoğlu, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Sep 2024, 1 month after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 1 month is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2024
First posted
Jul 25, 2024
StartActual
Jul 18, 2024
Primary completionEst.
Sep 1, 2024
CompletionEst.
Dec 31, 2024
Last update
Jul 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06520956
Lead sponsor
Istanbul Galata University
Responsible party
Safak Yigit (PhD(c), Istanbul Galata University) — Principal investigator
First posted
Jul 25, 2024
Start date
Jul 18, 2024
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 25, 2024

Study contacts

Habibe Serap Inal, Prof.Dr.
study director · Istanbul Galata University
Gülenay Yıldırım, MsC
principal investigator · Istanbul Galata University
Büşra Ülker Ekşi, PhD(c)
study chair · Istanbul Galata University
Şafak Yiğit, PhD(c)
study chair · Istanbul Galata University
Nejla Uzun, PhD
study chair · Istanbul Galata University
Alihan Bilen, PhD(c)
study chair · Istanbul Galata University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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