NCT04127955

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

February 13, 2020

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 8, 2019

Last Update Submit

February 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Changes in Blood Pressure

    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 baseline, before and after group walking and 1 , 2 and 3 months follow-up visits

  • Change in theory of planned behavior component

    Baseline,3-month follow up.

  • Change in The Problem Rating Scale

    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

    Health-related quality of life will be assessed baseline, the week right after the intervention and 1, 2 and 3 months follow-up visits

  • +3 more secondary outcomes

Study Arms (1)

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.

Other: Theory of Planned Behavior based Physical Activity Intervention

Interventions

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.

Intervention

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Selda SEÇGİNLİ, PhD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 16, 2019

Study Start

March 1, 2020

Primary Completion

July 1, 2020

Study Completion

December 15, 2020

Last Updated

February 13, 2020

Record last verified: 2019-10