NCT06161740

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

December 5, 2023

Last Update Submit

December 7, 2023

Conditions

Keywords

RehabilitationPhysiotherapyEndurance trainingMedical Research CouncilQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of life score

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

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

Secondary Outcomes (1)

  • Dyspnea score

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

Study Arms (2)

Muscle strengthening group MSG

ACTIVE COMPARATOR

It was based on exercises for strengthening the hip adductor muscles associated with a bridge using a small exercise ball (two sets of 15 repetitions with seven seconds in isometry), strengthening the hamstrings with ankle weights in prone position, bilateral hip flexor strengthening in supine position with ankle weights, bilateral shoulder flexor strengthening with dumbbells, bilateral shoulder extensor strengthening with dumbbells, bilateral shoulder abductor strengthening with dumbbells, and bilateral serratus anterior muscle strengthening with dumbbells (all exercises, except the first, performed in three sets of 10 repetitions). Considering a 15-second interval between repetitions and a one-minute break between sets, totaling 30 minutes. The progression of each patient occurred through load progression.

Procedure: muscle strengthening

Muscle strengthening associated with aerobic training group (MSGA)

EXPERIMENTAL

It initially consisted of a five-minute warm-up, divided into two minutes of stationary marching and three minutes of jumping jacks. Subsequently, patients were instructed to climb up and down ramps, ascend and descend stairs, walk on a flat surface, and use a cycle ergometer (each task performed for five minutes). For the recovery phase, bilateral stretching of the hamstrings, rectus femoris, triceps brachii, pectoralis major, sternocleidomastoid, and scalene muscles was performed, each lasting 30 seconds per muscle. The proposed protocol was associated with the anaerobic training described in the GF (muscle strengthening group).

Procedure: muscle strengthening

Interventions

The study involved adults aged 18 to 59 diagnosed with COVID-19 in the past year, experiencing mild or moderate symptoms, dyspnea, and either sedentary or engaging in physical exercise at least twice a week. Excluded were those with certain medical conditions. The participants were divided into two groups: one focused on global muscle strengthening (GF), and the other on low-intensity aerobic training with global muscle strengthening (GAF). The study assessed various parameters, including BMI, quality of life, aerobic capacity, dyspnea, and muscle strength. The sessions varied in duration and intensity. Volunteers were recruited from a clinic in Ubá-MG and randomly assigned to groups. The study aimed to evaluate the impact of the interventions on post-COVID-19 recovery.

Also known as: aerobic exercises
Muscle strengthening associated with aerobic training group (MSGA)Muscle strengthening group MSG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebert Olímpio Júnior

Divinésia, Brasil (+55), 36546000, Brazil

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 8, 2023

Study Start

August 16, 2022

Primary Completion

September 20, 2022

Study Completion

November 30, 2022

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations