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Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context

Primary Purpose

Elderly Women

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Program of physical exercises and health education by telerehabilitation
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly Women focused on measuring Health Services for the Aged, Telemonitoring, Exercise, Health Education, COVID-19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women aged 60 years or older;
  • Able to perform all the proposed assessments;
  • Not present cognitive impairment according to the assessment of mental status through the Mini Mental State Examination;
  • Participate in the supervised physical exercise program in person, prior to the beginning of the COVID-19 pandemic.

Exclusion Criteria:

  • had a frequency of participation in the program below 75%.

Sites / Locations

  • Franciele Marques Vanderlei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Baseline

Follow-up

Arm Description

Before the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index.

After the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index.

Outcomes

Primary Outcome Measures

Signs of sarcopenia
Sarcopenia will identify and track by the SARC-F questionnaire, composed of five self-reported questions, based on muscle strength activities, ambulation, rising from a chair, climbing stairs and history of falls, in combination with measurement of the right calf circumference as an indirect assessment of muscle mass. The total score will obtain by means of the sum of the questions (maximum 2 points for each) and the measurement of calf circumference (women: > 33 cm = 0; ≤ 33cm =10 points). This questionnaire is valid for Portuguese Language since 2016.
Physical Performance
Physical performance will be evaluated using the SPPB, a simple tool that can help to track the risk of falls by identifying risk factors related to the assessed domains. This tool has three domains: static balance, lower limbs strength and gait speed. The total SPPB score is made by adding these three domains and can vary between 0 and 12 points.
Hand Grip Strength
Hand grip strength will be assessed using a manual dynamometer (Crown produced by the industrial technique Oswaldo Filizola Ltda) with a capacity of 50 kilograms-force, following the protocol proposed by Robert et al. During the test, the participant remains seated with the forearms resting on the arms of the chair with wrists in a neutral position and her thumbs facing up. The evaluator assists by holding the base of the dynamometer in the palm of the hand in order to nullify the effect of gravity on the test, while the participant holds the dynamometer. In this way, the patient is asked to press as long and strong as possible or until the pointer stops rising. The test is performed three times in each hand, alternating between them, with an interval of 20 seconds for each attempt. The value recorded regarding strength was the highest among the six measures.
Anxiety symptoms
The GAI is an instrument designed to assess anxiety symptoms in elderly individuals, with viable application in situations of fatigue, low educational level or mild cognitive impairment. The inventory consists of 20 items with dichotomous responses, with a cut-off point of 10/11 for the detection of generalized anxiety disorder. The GAI will be translated and adapted into Brazilian Portuguese, called the Geriatric Anxiety Inventory (GAI-BR), contributing to a quick, effective and low-cost evaluation with satisfactory validity.
Depressive symptoms
The GDS-15 is a self-assessment scale that analyzes the presence of suspected depression in the elderly, easy to apply and low cost. Its reduced version consists of 15 questions, with dichotomous answers (yes/no), in which 0 points are scored when the answer is different from the example in parentheses and 1 point when the answer is the same as the example in parentheses. A 5-point cut-off for the GDS-15 indicates the presence of suspected depression.
Sleep quality
The PSQI is a questionnaire composed of 21 items that assesses subjective quality of sleep and disorders over the last month, in which 19 questions are self-assessment and 5 questions that must be answered by bedmates or roommates. The PSQI analyzes seven issues: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of sleeping medications, and daytime dysfunction. Its score ranges from 0 to 21 and indicates the overall quality of sleep, classifying individuals into good sleep quality (score less than 5) and poor sleep quality (score greater than 5), that is, the lower the score, the better the sleep quality score.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
August 16, 2022
Sponsor
Paulista University
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1. Study Identification

Unique Protocol Identification Number
NCT05465811
Brief Title
Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context
Official Title
Effects of Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University

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
Introduction: Due to the COVID-19 pandemic scenario, social distancing has become the main strategy to contain this pandemic, causing negative impacts on the physical and mental health of the elderly population. To promote the continuity of offering health services during isolation telerehabilitation was used. Thus, it is important to investigate the effect of a physical exercise program and health education through telerehabilitation on physical and mental aspects in order to establish it as an alternative care for the elderly. Objectives: To evaluate the effect of a program of physical exercises and health education by telerehabilitation on signs of sarcopenia, physical performance, hand grip strength and levels of anxiety, depression and sleep quality in elderly women. Method: In this non-randomized clinical trial, considered a pilot study, eight elderly women (73,00±4,69 years old) will be submitted to 16 weeks of intervention through a program of physical exercise and health education using the Google Meet platform (synchronous online), frequency of 3 weekly sessions and duration of 50' (Initial rest: 5'; Warm-up: 15': Resistance exercises: 20'; Stretching exercises: 5'; Relaxation and final rest: 5'). Before and after the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index. To compare the two moments, the paired Student's T-test or Wilcoxon test (normality assessed by the Shapiro-Wilk test) will be used with p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Women
Keywords
Health Services for the Aged, Telemonitoring, Exercise, Health Education, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
Experimental
Arm Description
Before the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index.
Arm Title
Follow-up
Arm Type
Experimental
Arm Description
After the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index.
Intervention Type
Other
Intervention Name(s)
Program of physical exercises and health education by telerehabilitation
Intervention Description
To carry out the telerehabilitation program, the Google Meet platform will be used in order to provide the synchronous service model. This will occur for a period of 16 weeks, three weekly sessions lasting 50 minutes, (total of 48 sessions). The sessions will be given by physiotherapists and students in their final year of graduation in physiotherapy, which will consist of the following phases: initial rest, warm-up, resistance exercises, stretching exercises, relaxation and final rest. In addition, in exchange for the warm-up phase, every 12 sessions, the telerehabilitation program also will have an approach through health education, using presentations, digital booklets and direct conversation between therapist and participants. The themes exhibited (importance of physical exercise in the pandemic context, reduction of the risk of falls through changes in the home environment and physiological changes resulting from aging) will intend to make them aware of better lifestyle habits.
Primary Outcome Measure Information:
Title
Signs of sarcopenia
Description
Sarcopenia will identify and track by the SARC-F questionnaire, composed of five self-reported questions, based on muscle strength activities, ambulation, rising from a chair, climbing stairs and history of falls, in combination with measurement of the right calf circumference as an indirect assessment of muscle mass. The total score will obtain by means of the sum of the questions (maximum 2 points for each) and the measurement of calf circumference (women: > 33 cm = 0; ≤ 33cm =10 points). This questionnaire is valid for Portuguese Language since 2016.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)
Title
Physical Performance
Description
Physical performance will be evaluated using the SPPB, a simple tool that can help to track the risk of falls by identifying risk factors related to the assessed domains. This tool has three domains: static balance, lower limbs strength and gait speed. The total SPPB score is made by adding these three domains and can vary between 0 and 12 points.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)
Title
Hand Grip Strength
Description
Hand grip strength will be assessed using a manual dynamometer (Crown produced by the industrial technique Oswaldo Filizola Ltda) with a capacity of 50 kilograms-force, following the protocol proposed by Robert et al. During the test, the participant remains seated with the forearms resting on the arms of the chair with wrists in a neutral position and her thumbs facing up. The evaluator assists by holding the base of the dynamometer in the palm of the hand in order to nullify the effect of gravity on the test, while the participant holds the dynamometer. In this way, the patient is asked to press as long and strong as possible or until the pointer stops rising. The test is performed three times in each hand, alternating between them, with an interval of 20 seconds for each attempt. The value recorded regarding strength was the highest among the six measures.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)
Title
Anxiety symptoms
Description
The GAI is an instrument designed to assess anxiety symptoms in elderly individuals, with viable application in situations of fatigue, low educational level or mild cognitive impairment. The inventory consists of 20 items with dichotomous responses, with a cut-off point of 10/11 for the detection of generalized anxiety disorder. The GAI will be translated and adapted into Brazilian Portuguese, called the Geriatric Anxiety Inventory (GAI-BR), contributing to a quick, effective and low-cost evaluation with satisfactory validity.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)
Title
Depressive symptoms
Description
The GDS-15 is a self-assessment scale that analyzes the presence of suspected depression in the elderly, easy to apply and low cost. Its reduced version consists of 15 questions, with dichotomous answers (yes/no), in which 0 points are scored when the answer is different from the example in parentheses and 1 point when the answer is the same as the example in parentheses. A 5-point cut-off for the GDS-15 indicates the presence of suspected depression.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)
Title
Sleep quality
Description
The PSQI is a questionnaire composed of 21 items that assesses subjective quality of sleep and disorders over the last month, in which 19 questions are self-assessment and 5 questions that must be answered by bedmates or roommates. The PSQI analyzes seven issues: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of sleeping medications, and daytime dysfunction. Its score ranges from 0 to 21 and indicates the overall quality of sleep, classifying individuals into good sleep quality (score less than 5) and poor sleep quality (score greater than 5), that is, the lower the score, the better the sleep quality score.
Time Frame
This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 60 years or older; Able to perform all the proposed assessments; Not present cognitive impairment according to the assessment of mental status through the Mini Mental State Examination; Participate in the supervised physical exercise program in person, prior to the beginning of the COVID-19 pandemic. Exclusion Criteria: had a frequency of participation in the program below 75%.
Facility Information:
Facility Name
Franciele Marques Vanderlei
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context

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