Elderly PeopleNCT06520956
Improving the Quality of Life of Elderly Individuals Living in Nursing Homes
A study testing Video based exercise group in people with Elderly People, run by Istanbul Galata University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly People
- What is being tested?
- Video based exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years or older,
- There is no health problem determined by the doctor that prevents physical activity,
- Volunteering to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Healthy Lifestyle Behaviors and Quality of Life of Elderly Individuals Living in Nursing Homes by Increasing Their Physical Activity Levels
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.
- Conditions
- Elderly People
- Being tested
- Video based exercise group
- Keywords
- Brain Breaks® (BB) videos, physical activity, quality of life, walking, health lifestyle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based exercise groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and at week 8
Secondary outcomes (6)
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'.
Measured: At baseline and at week 8
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).
Measured: At baseline and at week 8
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".
Measured: At baseline and at week 8
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.
Measured: At baseline and at week 8
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.
Measured: At baseline and at week 8
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).
Measured: At baseline and at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start18 Jul 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Galata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safak Yigit, Istanbul Galata University
- Investigators
- Habibe Serap Inal, Prof.Dr., Study director, Istanbul Galata UniversityGülenay Yıldırım, MsC, Principal investigator, Istanbul Galata UniversityBüşra Ülker Ekşi, PhD(c), Study chair, Istanbul Galata UniversityŞafak Yiğit, PhD(c), Study chair, Istanbul Galata UniversityNejla Uzun, PhD, Study chair, Istanbul Galata UniversityAlihan Bilen, PhD(c), Study chair, Istanbul Galata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520956
- Sponsor's protocol ID
- GalataU
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthy Lifestyle Behaviors and Quality of Life of Elderly Individuals Living in Nursing Homes by Increasing Their Physical Activity Levels
- ClinicalTrials.gov ID
- NCT06520956
- Acronym / sponsor ID
- GalataU
- Conditions
- Elderly People
- Keywords
- Brain Breaks® (BB) videos, physical activity, quality of life, walking, health lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Galata UniversityUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based exercise group | Experimental | Behavioral: Video based exercise groupIn 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 |
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being 65 years or older,
- There is no health problem determined by the doctor that prevents physical activity,
- Volunteering to participate in the study.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video based exercise groupIn 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. | Behavioural | Video-based exercise group |
Primary outcome
Six Minute Walking Test
Time frame: At baseline and at week 8
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).
6 secondary outcomes
Posture Evaluation
Time frame: At baseline and at week 8
Healthy Lifestyle Behaviors Scale II
Time frame: At baseline and at week 8
Sleep quality
Time frame: At baseline and at week 8
Life Satisfaction Scale
Time frame: At baseline and at week 8
Flexibility assessment
Time frame: At baseline and at week 8
Barthel Index
Time frame: At baseline and at week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video based exercise group in people with Elderly People, run by Istanbul Galata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walking Test (time frame: At baseline and at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.