NCT05022966

Brief Summary

Aging is a physiological process, and it is a picture in which a decrease in physical functions, regression in cognitive abilities, decrease in social activities, loss of functionality in their lives occur and these are accompanied by many health problems. As a result of the changes in the human body and mind, the productivity of the organism and the ability of the person to adapt to the environment decrease. According to the data of the World Health Organization, this period is considered to be 65 years and over, and according to the data of the United Nations, 60 years and over. The aim of this study is to investigate the effect of physical activity level on activities of daily living and fear of falling in elderlies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

August 22, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

Physical activityDaily life activitiesFear of falling

Outcome Measures

Primary Outcomes (3)

  • Physical Activity Scale For Elderly

    Physical Activity Scale For Elderly (PASE) includes participants' walking, mild, moderate, vigorous sports and recreational activities, muscle strength and endurance exercises, work-related activities including walking and standing, lawn and garden maintenance, caring for another person, home repairs, heavy-duty sports and recreational activities in the past week. Home and work-related activities are scored as yes or no. For work-related activities, paid or unpaid work is scored in hours per week. The total PASE score is calculated by multiplying the time spent in each activity (hours per week) or participation in an activity (ie yes or no) by the experimentally derived item weights, and then adding the overall activities. The overall PASE score ranges from 0 to 400 or more, with higher scores indicating better levels of physical activity.

    At baseline

  • Modified Barthel Index

    Modified Barthel Index is a 10-item scale that evaluates physical independence in activities of daily living (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). The total score (0-100) is calculated by scoring each item separately with a three-digit scoring system. The total score ranges from 0 to 100, where "0" indicates complete dependency and "100" indicates complete independence. The sensitivity of the index was increased by using a five-step scoring system in the Modified Barthel index modified by Shah.

    At baseline

  • Falls Efficacy Scale International

    Fall Effectiveness Scale-International (FES-I), developed and approved by the European Fall Prevention Network (ProFaNE), has become a widely accepted tool for assessing fall anxiety. The FES-I is a self-reported questionnaire that provides information on the level of anxiety about falls for a range of activities of daily living. The original questionnaire contains 16 items scored on a four-point scale (1 = not at all interested to 4 = very interested). The lowest score that can be obtained from the survey is 16 and the highest score is 64. A high score indicates an increased level of anxiety. The Turkish validity and reliability of the questionnaire was performed by Ulus et al.

    At baseline

Study Arms (1)

Older people

Other: No intervention

Interventions

Individuals did not received any intervention.

Older people

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study group of this research is planned to be composed of residents of Melmira Elderly Care Center and Nursing Home.

You may qualify if:

  • Volunteering to participate in the research
  • Being 60 years old or older
  • Staying in a nursing home for at least 1 month
  • Independent mobilization of the participants

You may not qualify if:

  • Having a problem that prevents communication
  • Having multiple comorbidities
  • Having a cognitive problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 26, 2021

Study Start

August 30, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations