NCT04250870

Brief Summary

Aging decreases the physical fitness levels in living beings. The environmental factors also have a major effect on the physical fitness levels. The objective of this study was to compare the physical fitness levels of nursing home residents and community-dwelling elderly people. This study employed 118 participants, who consisted of nursing home residents and community-dwelling elderly people. The physical fitness levels of the elderly people were measured by Senior Fitness Test. The physical fitness levels of the elderly people were measured by Senior Fitness Test. Chair stand test, arm curl test, 2-minute step test, chair sit and reach test, back-scratch test, 8-foot up and go test and body mass index were measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 5, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

January 30, 2020

Last Update Submit

January 30, 2020

Conditions

Keywords

agingcommunity dwellinghealthnursing homesphysical fitness

Outcome Measures

Primary Outcomes (1)

  • 2-minute step test

    The distance from the iliac crest to the midpoint of the patella was measured by a tape to determine the knee-stepping height. The midpoint of the distance between these two anatomical structures was determined. The height of the determined point from the ground was measured and marked on the wall. The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes. The total number of correct dominant side steps was recorded. If any of the participant's steps (right or left) did not reach the target height, those steps were considered invalid.

    2 hours

Study Arms (2)

Nursing Home Residents

ACTIVE COMPARATOR

Nursing home residents (n=59) were evaluated in five different nursing homes.

Diagnostic Test: Senior Fitness Test

Community-Dwelling Elderly

ACTIVE COMPARATOR

The community-dwelling elderly people (n=59) were selected from two different municipalities of the city.

Diagnostic Test: Senior Fitness Test

Interventions

Senior Fitness TestDIAGNOSTIC_TEST

Chair stand test:The number of full stands performed on a seated position that can be completed within 30 seconds was recorded. Arm curl test: The participants were asked to lift weights starting with a full elbow extension and then full flexion. 2-minute step test: The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes. Chair sit-and-reach test:The participant could extend right or left knee to a full extension, heel on the floor and ankle in a neutral position of 90 degrees. Then, the participant was asked to reach to the toes. Back-scratch test:The participant was asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible. 8-foot up and go test:The participant was asked to get up from a chair without any arm support and walk a distance of 2.44 meters; then turn around a cone and come back to sit down on the chair.

Community-Dwelling ElderlyNursing Home Residents

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65 and 85 years
  • Scored between 24 and 30 points in the Mini-Mental Status Examination (MMSE).
  • Living in nursing homes for at least six months (for nursing home residents) (6,7).

You may not qualify if:

  • Not able to communicate verbally
  • Not able to stand for at least 90 seconds and ambulated with assistance
  • Patients with severe visual impairment, neurological disorders and/or congestive heart failure
  • Individuals who are not advised exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PHD, Assoc Prof

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

January 5, 2019

Primary Completion

December 20, 2019

Study Completion

January 3, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations