COVID-19NCT06161740
Low-intensity Aerobic Training Associated With Global Muscle Strengthening in Post-COVID-19
A study testing muscle strengthening in people with COVID-19, run by Centro Universitário Augusto Motta at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- muscle strengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-intensity Aerobic Training Associated With Global Muscle Strengthening in Post-COVID-19 Individuals
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.
Read the 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.
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.
- Conditions
- COVID-19
- Being tested
- muscle strengthening
- Keywords
- Rehabilitation, Physiotherapy, Endurance training, Medical Research Council, Quality of Life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle strengtheningProcedure or surgery
Also called aerobic exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: muscle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
The low-intensity aerobic training associated with overall muscle strengthening will promote quality of life.
Measured: WHOQOL-bref questionnaire score was calculated before and after intervention, with a follow up of two months.
Secondary outcomes (1)
Dyspnea score
The low-intensity aerobic training associated with overall muscle strengthening will promote an effect, reducing dynapenia and dyspnea in adults post-COVID-19
Measured: MRC scale score was assessed before and after intervention, with a follow up of two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start16 Aug 2022
- Primary completion20 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161740
- Sponsor's protocol ID
- FUPAC
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-intensity Aerobic Training Associated With Global Muscle Strengthening in Post-COVID-19 Individuals
- ClinicalTrials.gov ID
- NCT06161740
- Acronym / sponsor ID
- FUPAC
- Conditions
- COVID-19
- Keywords
- Rehabilitation, Physiotherapy, Endurance training, Medical Research Council, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle strengthening group MSG | Active comparator | Procedure: muscle strengtheningIt 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. |
| Muscle strengthening associated with aerobic training group (MSGA) | Experimental | Procedure: muscle strengtheningIt 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle strengtheningAlso: aerobic exercisesThe 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. | Procedure or surgery | Muscle strengthening associated with aerobic training group (MSGA), Muscle strengthening group MSG |
Primary outcome
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.
1 secondary outcome
Dyspnea score
Time frame: MRC scale score was assessed before and after intervention, with a follow up of two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle strengthening in people with COVID-19, run by Centro Universitário Augusto Motta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: WHOQOL-bref questionnaire score was calculated before and after intervention, with a follow up of two months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.