Home-based Exercise in COVID-19 Survivors

NCT ID: NCT04615052

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-26

Study Completion Date

2022-09-30

Brief Summary

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The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.

Detailed Description

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Conditions

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Covid19 SARS (Severe Acute Respiratory Syndrome) SARS-CoV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise group

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.

Control group

The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with COVID-19
* Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
* Admitted in intensive care unit

Exclusion Criteria

* Cardiovascular disease
* Resting dyspnea
* Acute pulmonary embolism or pulmonary infarction
* Deep venous thromboembolism
* Uncontrolled visual or vestibular disorders
* Pregnancy
* Uncontrolled resting tachycardia
* Uncontrolled hypertension
* Uncontrolled Type II diabetes
* Acute infections
* Neurological disorders
* Patients with chronic kidney disease who are in need of hemodialysis
* Recent malignant neoplasm (\<5 years)
* Autoimmune diseases
* Complex ventricular arrhythmias, atrial fibrillation or complete heart block
* Transplant patients
* Any physical disabilities that could hamper physical testing and exercise program
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruno Gualano, PhD

Role: CONTACT

55112661 ext. 8021

Facility Contacts

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Bruno Gualano, Phd

Role: primary

551130918783

References

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Longobardi I, Goessler K, de Oliveira Junior GN, Prado DMLD, Santos JVP, Meletti MM, de Andrade DCO, Gil S, Boza JASO, Lima FR, Gualano B, Roschel H. Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial. Br J Sports Med. 2023 Oct;57(20):1295-1303. doi: 10.1136/bjsports-2022-106681. Epub 2023 May 10.

Reference Type DERIVED
PMID: 37164620 (View on PubMed)

Other Identifiers

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4.342.082

Identifier Type: -

Identifier Source: org_study_id

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