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Clinical Trials/NCT06161740
NCT06161740CompletedNot Applicable

Effect of Low-intensity Aerobic Training Associated With Global Muscle Strengthening in Post-COVID-19 Individuals

Centro Universitário Augusto Motta2 sites in 1 country17 target enrollmentStarted: August 16, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
17
Locations
2
Primary Endpoint
Quality of life score

Study Overview

Brief Summary

The study called "Effect of low-intensity aerobic training associated with global muscle strengthening in post-COVID-19 individuals" wants to check if doing easy workouts and strengthening muscles can make breathing problems better for adults who had COVID-19.

The participant has been apprised that potential benefits may be derived from the research, including the reception of treatment for pertinent complaints meeting the study's inclusion criteria. Conversely, they have also been briefed on possible discomforts and risks associated with the study, such as the exposure of their image to the therapist administering the treatment.

The participant acknowledges that their privacy will be upheld, ensuring the confidentiality of personal information, including their name or any other identifying data. It has been communicated that the participant reserves the right to decline participation in the study or withdraw consent at any point without the obligation to provide justification. Moreover, they are assured that opting out of the study will not result in any adverse consequences.

Detailed Description

Patients of both genders aged 18 to 59 years were included in the study. They had been diagnosed with COVID-19 in the past year, experienced mild or moderate symptoms, had shortness of breath, were either sedentary or engaged in physical exercise at least twice a week, and agreed to sign the Informed Consent Form. Excluded from the study were individuals hospitalized due to COVID-19, those diagnosed with chronic lung diseases, smokers, those who had undergone prior physiotherapeutic treatment for post-COVID-19 syndrome, individuals with a history of lower limb surgeries or fractures (within the last six months), BMI over 30 kg/m², and those with neurological, cognitive, or cardiac impairments.

The sample, selected for convenience, was divided into two distinct groups: the global muscle strengthening group (GF) and the low-intensity aerobic training associated with global muscle strengthening group (GAF). The GF comprised eight volunteers, while the GAF had nine, totaling eight sessions with a frequency of two interventions per week, lasting 30 minutes each for the GF and 60 minutes each for the GAF. Two assessments were conducted: one at admission and another at the end of the treatment.

Participants were recruited at the Dr. Cícero Brandon School Clinic of Faculty President Antônio Carlos in Ubá city, state of Minas Gerais, with authorization for data collection and infrastructure use signed by the study researchers and supervisor. Volunteers were assessed during the first session to ensure compliance with inclusion and exclusion criteria outlined in the medical history form. They were informed about the entire procedure and study objectives and subsequently guided to sign the Informed Consent Form, following Resolution 466/2012 of the National Health Council.

Body Mass Index (BMI) calculation was done using a Multilaser digital scale and a two-meter measuring tape. Quality of life was assessed using the abbreviated version of the WHOQOL-100, the WHOQOL-bref, consisting of 26 questions related to general quality of life, satisfaction with one's health, and domains of physical, psychological, social relationships, and the environment.

Aerobic capacity was evaluated through the Six-Minute Walk Test (6MWT), performed on a flat, obstacle-free 30-meter track. The objective was to analyze the farthest distance a patient could walk in six minutes without running, with the option to stop at any time without interrupting the timing. Standardized encouragement phrases were used every minute during the test.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients of both genders aged 18 to 59 diagnosed with COVID-19 in the past year
  • Patients experienced mild or moderate symptoms
  • Sedentary or engaged in physical exercise at least twice a week

Exclusion Criteria

  • Patients hospitalized due to COVID-19 diagnosed with chronic lung diseases
  • Patients underwent prior physiotherapeutic treatment for post-COVID-19 syndrome
  • History of surgeries or fractures in the lower limbs (within the last six months)
  • BMI over 30 kg/m²
  • Patients with neurological, cognitive, or cardiac impairments

Outcomes

Primary Outcomes

Quality of life score

Time Frame: WHOQOL-bref questionnaire score was calculated before and after intervention, with a follow up of two months.

The low-intensity aerobic training associated with overall muscle strengthening will promote quality of life.

Secondary Outcomes

  • Dyspnea score(MRC scale score was assessed before and after intervention, with a follow up of two months)

Investigators

Sponsor
Centro Universitário Augusto Motta
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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