NCT05249764

Brief Summary

The physical fitness and functionality of older adults are affected during the COVID-19 Pandemic. Regular exercise programs are effective in physical fitness and functioning in older adults. Individualized and supervised exercise programs for older adults in a safe environment can improve physical fitness and functionality. This study aims to examine the effect of home-based and exercise training on physical fitness and functionality in sedentary older adults during the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

February 17, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

ExercisePhysical FitnessFunctionalityOlder adults

Outcome Measures

Primary Outcomes (6)

  • Change from baseline lower extremitu muscle strength at 8 weeks

    The chair stand test determines the muscle strength of the lower extremities. The older adult seat on a chair without arm support, with his/her feet on the ground and arms cross in the front of the chest. The number of full stands from the seated position perform within 30 seconds is recorded.

    Before the program and after eight weeks program

  • Change from baseline upper extremity muscle strength at 8 weeks

    The arm curl test determines the upper extremity muscle strength. The older adult seat towards the dominant side on a chair without arm support. In this test, older women and men lift weights of 2.27 and 3.63 kilograms, respectively, starting with a full elbow extension with dominant arms and flexing the elbow to full flexion. The total number of lifts perform for 30 seconds is recorded.

    Before the program and after eight weeks program

  • Change from baseline aerobic endurance at 8 weeks

    The 2-minute step test measures the aerobic endurance of the older adults as an alternative to the 6-minute walk test. The distance from the iliac crest to the midpoint of the patella is measured by a tape to determine the knee-stepping height. The midpoint between these two anatomical structures is determined. The height of the determined point from the ground is measured and marked on a wall. The older adult begins stepping as quickly as possible to reach the marked height for two minutes. The total number of correct steps is recorded. If any of the steps (right or left) do not reach the target height, those steps are considered invalid.

    Before the program and after eight weeks program

  • Change from baseline lower extremity flexibility at 8 weeks

    The Chair sit-and-reach test is a modified form of the sit-and-reach test, which determines the flexibility of the hamstring muscle group. The older adult sits on the front of a chair. Then they extend the right or left knee to a full extension, the heel on the floor, and ankle in a neutral position of 90 degrees. The other knee is flexed to approximately 90 degrees. Then, the older adult is asked to reach the toes of the extended limb with his/her same side upper limb. If the middle finger could not reach to the toes, the distance is recorded as a 'minus' score; if it could touch the toes, then a distance of 'zero' score is recorded; and if it could reach past the toes, then the distance is recorded as a 'plus' score.

    Before the program and after eight weeks program

  • Change from baseline upper extremity flexibility at 8 weeks

    The Back scratch test evaluates the flexibility of the upper extremities. The older adult is 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. Then the researcher want the older adult to place the other arm around the back of the waist with the palm up and reach up the other hand. The distance between the middle fingers of both hands is measured with a tape. If the middle fingers do not touch each other, the distance is recorded as a 'minus' score, if it reaches the other, then a 'zero' score is recorded as; and if fingers could cross each other, then 'plus' score is recorded.

    Before the program and after eight weeks program

  • Change from baseline balance and agility at 8 weeks

    The 8-foot up and go test determines the dynamic balance and agility of the older adults. The older adult gets up from a chair without any arm support and walk 2.44 meters as quickly as possible; then turn around a cone (at a specified position) and come back to sit down on the chair. The time between the older adults' starting movement and sitting down on the chair is recorded in seconds.

    Before the program and after eight weeks program

Secondary Outcomes (3)

  • Change from baseline Berg Balance Scale at 8 weeks

    Before the program and after eight weeks program

  • Change from baseline Timed up and go test at 8 weeks

    Before the program and after eight weeks program

  • Change from baseline Tinetti Fall Efficancy Scale at 8 weeks

    Before the program and after eight weeks program

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.

Other: Supervised Home Based Exercise Training

Control

ACTIVE COMPARATOR

Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.

Other: Unsupervised stretching and breathing exercises

Interventions

Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.

Exercise

Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.

Control

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged between 65-85 years
  • Individuals have 24 points and above from the Standardized Mini-Mental State Examination
  • Sedentary individuals whose physical activity levels are inactive or minimally active group according to the Short form of International Physical Activity Questionnaire (IPAQ-SF).
  • Individuals who can stand for at least 90 seconds without assistance
  • Individuals who voluntarily agree to participate in the study
  • Individuals who have not suffered from COVID infection.

You may not qualify if:

  • Individuals who have malignancy
  • Individuals who are ambulatory with assistance
  • Individuals who have severe vision loss
  • Individuals who have a neurological disease (Stroke, Parkinson, Multiple Sclerosis)
  • Individuals who had surgery in the last six months
  • Individuals who have congestive heart failure
  • Individuals who have received exercise training in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary BehaviorCOVID-19Motor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the study and control group do not know the content of the exercise program. All groups are taking exercise programs individually at their home. So that individuals are not aware of the groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PHd, Professor, lecturer in Baskent University

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 22, 2022

Study Start

January 5, 2022

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations