Physical ActivityNCT04127955
A Nurse-led Theory of Planned Behavior Based Physical Activity Intervention Among Turkish Adults
A study testing Theory of Planned Behavior based Physical Activity Intervention in people with Physical Activity, run by Istanbul University - Cerrahpasa.
Trial summary
The Theory of Planned Behavior has been successfully used in several programs to improve physical activity behavior. In this project, it is aimed to assess the effectiveness of Theory of Planned Behavior based physical activity intervention applied to 55-74 years old people living in nursing home in Turkey. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Theory of Planned Behavior based Physical Activity Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to 15 Dec 2020
- 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 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the study
- Aged 55 to 74
- Cognitive function of a score of greater than 24 on the Mini Mental State Examination
- Sedentary (Omaha system physical activity status ratings 1 or 2 score)
- To know Turkish literacy
- Time and go test score <14 seconds
- Approval of the resident's General Practitioner to participate
Who cannot join
- Uncontrolled cardiovascular, musculoskeletal or neurological disorders.
- Pain in motion or acute
- Communication barrier (due to hearing/vision impairment )
- > 3 falls in the previous year
- Need an walking aid (walkers, cane, crutches, walking sticks, etc.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Theory of Planned Behavior Based Physical Activity Intervention Among 55-74 Years Turkish Adults Living in Nursing Home
The Theory of Planned Behavior has been successfully used in several programs to improve physical activity behavior. In this project, it is aimed to assess the effectiveness of Theory of Planned Behavior based physical activity intervention applied to 55-74 years old people living in nursing home in Turkey.
- Conditions
- Physical Activity
- Being tested
- Theory of Planned Behavior based Physical Activity Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of Planned Behavior based Physical Activity InterventionOther
Health education: The first component of intervention consisted of one session 30 minutes educational lesson relation to physical activity.
Group walking: The format of the 15-minute group walking session included 5 minutes of warm-up, 5 minute moderate intensity walking, 5 minute cool-down.
Counseling (individually tailored): The nurse received training about motivational interview technique for use in their physical activity counseling with participants. Using pedometers and step diary to set goals and monitor progress.
Pedometer: pedometer will be used objective physical activity assessment. Measurement of physical activity levels, wearing a pedometer (Omron HJ321E) on a belt over one hip, all day for 7 days, removing for bathing and sleeping. A diary is also provided to record step count. The pedometer will be used for baseline and outcome measurement of step-counts for the trial.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Quasi-experimental design with one-group, pre-post test
A nurse-led Theory of Planned Behavior based Physical Activity intervention consists of five component. These are a health education, a group walking, an individually tailored counseling session grounded on motivational interview technique, having the individuals keep track their physical activity levels with a pedometer, and use of physical activity pamphlet and posters as a reminder was planned. This intervention will be completed in eight weeks. Receives: Other: Theory of Planned Behavior based Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily steps
The number of steps weekly by the pedometer.
The number of steps will be evaluated for the first time in the 3rd week of the intervention and each week until the end of the intervention (week 3-8).
Measured: Average daily steps will be assessed intervention period at week 3-8 and 1 , 2 and 3 months follow-up visits.
Secondary outcomes (8)
Changes in Blood Pressure
Blood pressure will be assessed between baseline, before and after group walking and 1, 2, 3 months after the intervention using the upper arm blood pressure monitors (Omron M3 Comfort®, HEM-7134-E)
Measured: Blood pressure will be assessed baseline, before and after group walking and 1, 2 and 3 months follow-up visits
Changes in heart rate
Heart rate will be assessed between baseline, before and after group walking and 1, 2, 3 months after the intervention using blood pressure monitors (Omron M3 Comfort®, HEM-7134-E)
Measured: Heart rate will be assessed baseline, before and after group walking and 1 , 2 and 3 months follow-up visits
Change in theory of planned behavior component
Theory of planned behavior components are including attitude, subjective norm, perceived behavior control, intention and behavior. The response used likert 1-7 format.
Measured: Baseline,3-month follow up.
Change in The Problem Rating Scale
The Omaha System include three components which are the Problem Classification Scheme, the Intervention Scheme, and the Problem Rating Scale for Outcomes. In this study, the Problem Rating Scale is used that evaluates the level of the problem and the results of the intervention. Change in physical activity measured with Omaha System Problem Rating Scale for Outcomes in which knowledge, behavior, status are rated on five-point Likert-type scales (1 = lowest / worse score, 5 = highest /best score). For example, a nurse may document a client's physical activity Knowledge as 1 (no knowledge), Behavior as 4 (Usually appropriate behavior), and Status as 2 (Severe signs/ symptoms).
Measured: Change in physical activity will be assessed baseline, the week right after the intervention and 1 , 2 and 3 months follow-up visits
Changes in health-related quality of life
EQ-5D three-level version (EQ-5D-3L) descriptive systems is a five-dimensions questionnaire about the topics "mobility", "self-care", "usual-activities", "pain/discomfort" and "anxiety/depression".
Measured: Health-related quality of life will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits
Changes in EQ-VAS
Visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined
Measured: Visual analogue scale (VAS) of EQ-5D Questionnaire will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits
Change in Body Mass Index (BKI)
Weight (kg) will be measured using a balance scale with the measurement taken to the nearest 0.1 kg. Height (cm) will be measured using a stadiometer with the measurement taken to the nearest 0,5 cm. Weight and Height measurements will be then used to calculate the body mass index [BMI: Weight (kg) / (Height) 2 (m2)].
Measured: BKI will be assessed baseline, the week right after the intervention and 3 months follow-up visit
Change in waist hip ratio
Waist circumference was measured at the level of the umbilicus to the nearest 0.1 cm. Hip circumference was measured at the level of the trochanter major. The waist / hip ratio was calculated as waist circumference (cm)/ hip circumference (cm).
Measured: Waist / hip ratio will be assessed baseline, the week right after the intervention and 3 months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study startMar 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Baz, Bahçeşehir University
- Investigators
- Selda SEÇGİNLİ, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127955
- Sponsor's protocol ID
- IUC
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 13 Feb 2020
- 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 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Theory of Planned Behavior Based Physical Activity Intervention Among 55-74 Years Turkish Adults Living in Nursing Home
- ClinicalTrials.gov ID
- NCT04127955
- Acronym / sponsor ID
- IUC
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 16 Oct 2019 (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 Theory of Planned Behavior has been successfully used in several programs to improve physical activity behavior. In this project, it is aimed to assess the effectiveness of Theory of Planned Behavior based physical activity intervention applied to 55-74 years old people living in nursing home in Turkey.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Theory of Planned Behavior based Physical Activity InterventionQuasi-experimental design with one-group, pre-post test A nurse-led Theory of Planned Behavior based Physical Activity intervention consists of five component. These are a health education, a group walking, an individually tailored counseling session grounded on motivational interview technique, having the individuals keep track their physical activity levels with a pedometer, and use of physical activity pamphlet and posters as a reminder was planned. This intervention will be completed in eight weeks. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to participate in the study
- Aged 55 to 74
- Cognitive function of a score of greater than 24 on the Mini Mental State Examination
- Sedentary (Omaha system physical activity status ratings 1 or 2 score)
- To know Turkish literacy
Key exclusion criteria (5 listed)
- Uncontrolled cardiovascular, musculoskeletal or neurological disorders.
- Pain in motion or acute
- Communication barrier (due to hearing/vision impairment )
- > 3 falls in the previous year
- Need an walking aid (walkers, cane, crutches, walking sticks, etc.)
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 |
|---|---|---|
| Theory of Planned Behavior based Physical Activity InterventionHealth education: The first component of intervention consisted of one session 30 minutes educational lesson relation to physical activity. Group walking: The format of the 15-minute group walking session included 5 minutes of warm-up, 5 minute moderate intensity walking, 5 minute cool-down. Counseling (individually tailored): The nurse received training about motivational interview technique for use in their physical activity counseling with participants. Using pedometers and step diary to set goals and monitor progress. Pedometer: pedometer will be used objective physical activity assessment. Measurement of physical activity levels, wearing a pedometer (Omron HJ321E) on a belt over one hip, all day for 7 days, removing for bathing and sleeping. A diary is also provided to record step count. The pedometer will be used for baseline and outcome measurement of step-counts for the trial. | Other | Intervention |
Primary outcome
Change in average daily steps
Time frame: Average daily steps will be assessed intervention period at week 3-8 and 1 , 2 and 3 months follow-up visits.
The number of steps weekly by the pedometer. The number of steps will be evaluated for the first time in the 3rd week of the intervention and each week until the end of the intervention (week 3-8).
8 secondary outcomes
Changes in Blood Pressure
Time frame: Blood pressure will be assessed baseline, before and after group walking and 1, 2 and 3 months follow-up visits
Changes in heart rate
Time frame: Heart rate will be assessed baseline, before and after group walking and 1 , 2 and 3 months follow-up visits
Change in theory of planned behavior component
Time frame: Baseline,3-month follow up.
Change in The Problem Rating Scale
Time frame: Change in physical activity will be assessed baseline, the week right after the intervention and 1 , 2 and 3 months follow-up visits
Changes in health-related quality of life
Time frame: Health-related quality of life will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits
Changes in EQ-VAS
Time frame: Visual analogue scale (VAS) of EQ-5D Questionnaire will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits
Change in Body Mass Index (BKI)
Time frame: BKI will be assessed baseline, the week right after the intervention and 3 months follow-up visit
Change in waist hip ratio
Time frame: Waist / hip ratio will be assessed baseline, the week right after the intervention and 3 months follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
Selda SEÇGİNLİ, PhD study director
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Theory of Planned Behavior based Physical Activity Intervention in people with Physical Activity, run by Istanbul University - Cerrahpasa.
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 7 inclusion and 5 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Selma BAZ, Msc (0212 381 00 00 ext. 9112, selma.baz@ogr.iu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily steps (time frame: Average daily steps will be assessed intervention period at week 3-8 and 1 , 2 and 3 months follow-up visits.). 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 13 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.