NCT04615052

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

October 29, 2020

Last Update Submit

June 10, 2022

Conditions

Covid19SARS (Severe Acute Respiratory Syndrome)SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.

    Higher score means better outcome.

    Baseline and 16 weeks.

Secondary Outcomes (35)

  • Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.

    Baseline and 16 weeks.

  • Change from baseline on lipid profile at 16 weeks.

    Baseline and 16 weeks.

  • Change from baseline on insulin sensitivity at 16 weeks.

    Baseline and 16 weeks.

  • Change from baseline on inflammatory cytokine IL-1 at 16 weeks.

    Baseline and 16 weeks.

  • Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.

    Baseline and 16 weeks.

  • +30 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL
Other: Exercise training

Control group

NO INTERVENTION

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

Interventions

Exercise trainingOTHER

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.

Exercise group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37164620DERIVED

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Bruno Gualano, PhD

CONTACT

55112661gualano@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

September 26, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

BR(1)