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

NCT ID: NCT05465811

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-08-16

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.

Conditions

Elderly Women

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline

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.

Group Type: EXPERIMENTAL

Program of physical exercises and health education by telerehabilitation

Intervention Type: OTHER

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.

Follow-up

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.

Group Type: EXPERIMENTAL

Program of physical exercises and health education by telerehabilitation

Intervention Type: OTHER

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.

Interventions

Program of physical exercises and health education by telerehabilitation

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.

Intervention Type: OTHER

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%.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Paulista University

OTHER

Sponsor Role: lead

Responsible Party

Franciele Marques Vanderle

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, Brazil

Countries

Brazil

Other Identifiers

54143121.1.0000.5402

Identifier Type: -

Identifier Source: org_study_id