Elderly WomenNCT05465811
Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context
A study testing Program of physical exercises and health education by telerehabilitation in people with Elderly Women, run by Paulista University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Women
- What is being tested?
- Program of physical exercises and health education by telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2022to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- had a frequency of participation in the program below 75%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context: A Pilot Study
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.
- Conditions
- Elderly Women
- Being tested
- Program of physical exercises and health education by telerehabilitation
- Keywords
- Health Services for the Aged, Telemonitoring, Exercise, Health Education, COVID-19
- Medical subject headings
- Motor Activity, Health Education, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of physical exercises and health education by telerehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Experimental | 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. Receives: Other: Program of physical exercises and health education by telerehabilitation |
| Follow-up | Experimental | 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. Receives: Other: Program of physical exercises and health education by telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start10 Jan 2022
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465811
- Sponsor's protocol ID
- 54143121.1.0000.5402
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context: A Pilot Study
- ClinicalTrials.gov ID
- NCT05465811
- Acronym / sponsor ID
- 54143121.1.0000.5402
- Conditions
- Elderly Women
- Keywords
- Health Services for the Aged, Telemonitoring, Exercise, Health Education, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | Experimental | Other: Program of physical exercises and health education by telerehabilitationBefore 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. |
| Follow-up | Experimental | Other: Program of physical exercises and health education by telerehabilitationAfter 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- had a frequency of participation in the program below 75%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program of physical exercises and health education by telerehabilitationTo 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. | Other | Baseline, Follow-up |
Primary outcome
Signs of sarcopenia
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program of physical exercises and health education by telerehabilitation in people with Elderly Women, run by Paulista University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of sarcopenia (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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.