NCT04346953

Brief Summary

In December 2019, new coronavirus pneumonia (COVID-19) broke out in Wuhan (Hubei, China), and it spread rapidly from one city to the whole country in just 30 days, and then worldwide cases began to appear. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared as "pandemic". Apart from compulsory situations, non-home and social isolation are the primary measures. However, not leaving the house and social isolation brings with it the restriction of physical activity. According to World Health Organization (WHO), in order to obtain health benefits, adult individuals between the ages of 18-64 should perform at least 150 minutes of physical activity per week (30 minutes a day for 5 days a week) or intensive physical activity for at least 75 minutes a week. For additional health benefits, adults should increase their moderate-intensity physical activities to at least 300 minutes a week or equivalent. Physical activity; It is directly related to the prevention of chronic diseases, increasing fitness, strengthening the muscles and increasing the quality of life. It is reported that one of the ten main risk factors in terms of mortality in the world is insufficient physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. Practical and innovative interventions are needed to reduce physical performance and decrease in muscle mass, strength and physical performance in the aging population. Considering today's conditions and current COVID-19 Pandemic, technology-supported exercise programs are effective in increasing the motivation for physical activity. The purpose of this study; In order to prevent the spread of the COVID-19 pandemic, social isolation, which is one of the measures taken in our country, is to evaluate the physical activity level of adults and to investigate the effectiveness of home exercises. It is aimed to use a model based on the video supported by a home-based exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

April 13, 2020

Last Update Submit

February 7, 2022

Conditions

Keywords

Social isolationExercisesPhysical inactivityHealth benefits

Outcome Measures

Primary Outcomes (7)

  • International Physical Activity Questionnaire - Short Form

    The International Physical Activity Questionnaire -Short Form (IPAQ-SF) measures the frequency and duration of moderate physical activity, vigorous physical activity, walking, and sedentary behavior using 7 questions and is considered more suitable for population surveillance and large-scale studies compared with the long form . The IPAQ-SF was validated for adults.According to the score obtained, the physical activity levels of individuals are determined. It indicates lower physical activity level below 600 Metabolic Equivalent Threshold (MET)-min per week, medium physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week and high physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week.

    2 weeks

  • Nottingham Health Profile

    Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.

    2 weeks

  • Beck Depression Inventory

    It is among the most used scales to measure depression all over the world. It consists of 21 questions in total. Each item gets points between 0-3. 11-17 points indicate mild depression, 18-29 points indicate moderate depression, and 30-63 points indicate severe depression.

    2 weeks.

  • Beck Anxiety Inventory

    It is used to evaluate the anxiety symptoms experienced by individuals due to social isolation. It consists of 21 items and is scored between 0-3. It indicates low anxiety of 0-21 points, moderate anxiety of 22-35 points and high anxiety of 36 points and above.

    2 weeks

  • Pittsburgh Sleep Quality Index

    It is a scale that provides information about sleep quality and type and severity of sleep disorder in the last month. The sleep quality of the person on this scale; sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. Each question is given a score of 0-3. High scores reflect poor sleep quality. If the total score obtained from the scale is less than 5, it is defined as "Good sleep quality" and 5 and above is defined as "Bad sleep quality".

    2 weeks

  • Timed Get Up and Go Test

    Used for mobility assessment. The test begins while the person is sitting in the chair. The person is asked to get up from the chair, walk 3 meters, come back and sit on the chair again, and the time is recorded. If an elderly person completes the test for more than 12 seconds, there is a risk of falling.

    2 weeks

  • Flamingo Balance Test

    Flamingo Balance Test will be used to evaluate the static balance of the individuals who will participate in the study. This test is done on one foot. While individuals are in balance with one foot, time begins and tries to stay in balance for 1 minute. The time is stopped when the balance is disturbed. When the time is completed, each individual attempt to balance is counted and this number is recorded as the individual's score at the end of the test. If the individual tries to balance 15 times in the first 30 seconds, the test is stopped and zero points are given.

    2 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

The group to which the exercise videos consisting of aerobic and strengthening exercises will be applied.

Behavioral: Video based exercise

Control Group

NO INTERVENTION

The control group where only the evaluations will be made and information about the benefits of exercise will be given.

Interventions

Individuals (n = 64) to be included in the study group will be grouped according to the levels of physical activity (low, medium, high level) determined by the International Physical Activity Questionnaire. An exercise program will be created for each group based on physical activity levels and videos of these exercise programs will be prepared. The videos will be scheduled for 20 minutes. Individuals will be asked to apply for these programs with video for 20 minutes every day for 6 weeks. Exercise programs will start with pulmonary exercises and warm-up exercises to prepare for exercise. The exercise program will end with cool down exercises. The exercise protocol will be determined as a combination of aerobic and strengthening exercises.

Study Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 40-60 years old
  • Being in social isolation due to COVID-19 virus
  • Not having any physical disability that prevents them from doing physical activities
  • Being in social isolation due to COVID-19 virus
  • Having access to exercise videos

You may not qualify if:

  • Having a serious cognitive impairment
  • Having serious hearing and vision problems
  • Having vestibular disorders that can cause loss of balance
  • Having diabetes and/or hypertension or a neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Social IsolationMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD, Associate Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

August 20, 2020

Primary Completion

October 1, 2020

Study Completion

November 30, 2020

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations