search
Back to results

Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)

Primary Purpose

Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Kubra Koce, MSc PT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Telerehabilitation focused on measuring Covid-19, Exercises, Social Isolation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being 65 years old and over
  • Being in social isolation due to the 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.

Exclusion Criteria:

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

Sites / Locations

  • Istanbul university Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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

Control group where evaluations will be made.

Outcomes

Primary Outcome Measures

Physical Activity Scale for the Elderly
One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.
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.
Loneliness Scale for the Elderly
It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2020
Last Updated
January 30, 2021
Sponsor
Kubra Koce, MSc PT
search

1. Study Identification

Unique Protocol Identification Number
NCT04334434
Brief Title
Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)
Official Title
Investigation Of The Effectiveness Of The Telerehabilitation Applied To Individuals Over The Age Of 65 Who Experience Social Isolation At Houses Due To The Coronavirus (Covid-19) Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kubra Koce, MSc PT

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. 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 and the possibility of having both health risk behaviors together. 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. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation
Keywords
Covid-19, Exercises, Social Isolation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
The group to which the exercise protocol consisting of aerobic and strengthening exercises will be applied.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group where evaluations will be made.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
15 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. An online exercise protocol was created for individuals who will participate in the study. Each exercise session was planned as 30 minutes for 3 days a week for 4 weeks. 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 and strengthening exercises. Individuals were asked to participate in the study via Skype and aimed to do their exercises with a physiotherapist
Primary Outcome Measure Information:
Title
Physical Activity Scale for the Elderly
Description
One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.
Time Frame
2 weeks
Title
Nottingham Health Profile
Description
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.
Time Frame
2 weeks
Title
Loneliness Scale for the Elderly
Description
It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.
Time Frame
2 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being 65 years old and over Being in social isolation due to the 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. Exclusion Criteria: Having a serious cognitive impairment Having serious hearing and vision problems Having vestibular disorders that can cause loss of balance Having diabetes, hypertension or a neurological disease
Facility Information:
Facility Name
Istanbul university Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)

We'll reach out to this number within 24 hrs