Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06161740 |
| Other study ID # |
FUPAC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2022 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Centro Universitário Augusto Motta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The Medical Research Council (MRC) Dyspnea Scale was used to categorize the degree of
dyspnea, with patients choosing an item corresponding to the proportion of limitation caused
by dyspnea in their daily activities. Muscle strength measurement was conducted for each
volunteer using a validated digital scale in the quadriceps (90° knee flexion), hamstrings
(90° knee flexion), biceps brachii (90° elbow flexion), triceps brachii (anatomical
position), and deltoid (midportion, 30° shoulder abduction).
Blood pressure, heart rate, and oxygen saturation were measured at the beginning and end of
each session using a premium brand sphygmomanometer and stethoscope, a G-tech pulse oximeter,
and assessed throughout the session. Difficulty levels in performing proposed activities,
considering peripheral musculature, were queried using the Borg Scale.
The GF group focused on exercises for strengthening hip adductor muscles associated with
bridge exercises using a small exercise ball, hamstring strengthening 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 in three sets of 10 repetitions). Progression was based on each patient's development.
The GAF protocol initially involved a five-minute warm-up, consisting of two minutes of
stationary marching and three minutes of jumping jacks. Patients were then 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 hamstrings, rectus femoris, triceps brachii, pectoralis major,
sternocleidomastoid, and scalene muscles was performed, each lasting 30 seconds. This
protocol was associated with the anaerobic training described in the GF.
Volunteers were allocated to two groups using a simple random sampling method with two
blocks. Results were placed in sealed envelopes, concealing the patient allocation sequence
from the researcher.
