A Nurse-led Theory of Planned Behavior Based Physical Activity Intervention Among Turkish Adults

Physical Activity Clinical Trial

Official title:

Effectiveness of Theory of Planned Behavior Based Physical Activity Intervention Among 55-74 Years Turkish Adults Living in Nursing Home

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04127955
• Other study ID #: IUC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2019
• Source: Istanbul University-Cerrahpasa
• Contact: Selma BAZ, Msc
• Phone: 0212 381 00 00
• Email: selma.baz[@]ogr.iu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 15, 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• Theory of Planned Behavior based Physical Activity Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Average daily steps will be assessed intervention period at week 3-8 and 1 , 2 and 3 months follow-up visits.
Secondary	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)	Blood pressure will be assessed baseline, before and after group walking and 1, 2 and 3 months follow-up visits
Secondary	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)	Heart rate will be assessed baseline, before and after group walking and 1 , 2 and 3 months follow-up visits
Secondary	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.	Baseline,3-month follow up.
Secondary	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).	Change in physical activity will be assessed baseline, the week right after the intervention and 1 , 2 and 3 months follow-up visits
Secondary	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".	Health-related quality of life will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits
Secondary	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	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
Secondary	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)].	BKI will be assessed baseline, the week right after the intervention and 3 months follow-up visit
Secondary	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).	Waist / hip ratio will be assessed baseline, the week right after the intervention and 3 months follow-up visit