NCT04480606

Brief Summary

Due to the COVID-19 pandemic in our country, individuals over 65 are prohibited from leaving their homes by T.C. The Ministry of Internal Affairs on March 21, 2020. While social isolation provides protection from COVID-19, it also brings some side effects that pose health risks. Studies investigating the relationship between social isolation and health behavior report that individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking. Physical activity is any body movement produced by the contraction of skeletal muscles that increases energy consumption. 150 minutes of moderate PA, 75 minutes of severe PA per week, or combined moderate and severe intensity PA plus twice a week strength training is recommended for elderly. The prevalence of physical inactivity increases significantly with increasing age. At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. The purpose of this study; to evaluate the physical activity level, functional capacity and quality of life of individuals over the age of 65 who socially isolated due to the precautions COVID-19 pandemic, and to investigate the effectiveness of video based home exercise program.

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
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 16, 2020

Last Update Submit

July 16, 2020

Conditions

Keywords

elderlyCOVID 19physical activity

Outcome Measures

Primary Outcomes (3)

  • Physical Activity Scale for the Elderly

    Physical Activity Scale for the Elderly will use to assess the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile. The minimum and maximum score that can be obtained from the scale is 0 and 400.The higher score indicates better level of physical activity.

    6 weeks

  • Nottingham Health Profile

    Nottingham Health Profile will use to assess the quality of life related to health. It is a general quality of life questionnaire that assesses the level of individuals' health problems and how they affect their daily life activities. It have six subtitles, scored between 0-100. The high total score indicates that the health condition is bad.

    6 weeks

  • Short Physical Performance Battery

    Short Physical Performance Battery will use to assess physical performance. This test consists of 3 objective tests that evaluate lower body function; 4 meters walking, getting up from the chair and standing balance test. 5-step (0-4) summary score is assigned for each test; higher scores show better physical performance.

    6 weeks

Secondary Outcomes (3)

  • Beck anxiety inventory

    6 weeks

  • Beck depression inventory

    6 weeks

  • Contentment With Life Scale

    6 weeks

Study Arms (2)

Home exercise group

EXPERIMENTAL

47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group.

Behavioral: Home exercise program

Control Group

NO INTERVENTION

The control group will be asked to remain isolated as they are and the exercise program will not be implemented.

Interventions

47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity.

Home exercise group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years old and over
  • Being in social isolation due to coronavirus epidemic
  • Spending at least 1 week at home different from routine life
  • Not to be obstructed from doing physical activities
  • To have access to online exercise training

You may not qualify if:

  • Having serious cognitive impairment (Mini-mental state examination being lower than 24)
  • Having serious hearing and vision problems
  • Having vestibular disorders that can cause loss of balance
  • having serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

August 1, 2020

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share