Covid19NCT04767477
Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors
A study testing Face-to-face rehabilitation and Telerehabilitation in people with Covid19 and Exercise Tolerance, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Exercise Tolerance, Quality of Life
- What is being tested?
- Face-to-face rehabilitation and Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Mar 2021to 10 Sep 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both genders;
- With a diagnosis of COVID-19 confirmed by a laboratory through RT-PCR means;
- Have to access to the internet and some device (smartphone, computer or notebook) that allows them to participate in the call centre.
Who cannot join
- Individuals with orthopaedic or neurological diseases;
- Individuals with difficulties in understanding and that present psychological changes that make it difficult or impossible to understand the information presented.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol
INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Thus, rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE: To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study. Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED RESULTS: This work will bring important information to the scientific community and health professionals, about the best forms of intervention and its repercussions on the surviving individuals of COVID-19.
- Conditions
- Covid19, Exercise Tolerance, Quality of Life, Lung Function, Fatigue Intensity
- Being tested
- Face-to-face rehabilitation, Telerehabilitation
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face rehabilitationOther
Aerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions.
TelerehabilitationOther
The telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face rehabilitation and Telerehabilitation | Other | The Face-to-face rehabilitation and Telerehabilitation protocol will consist of flexibility exercises, aerobic and resistance training, with two sessions per week. Receives: Other: Face-to-face rehabilitation; Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum functional capacity
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption
Measured: 12 weeks
Submaximal functional capacity
Evaluated by the six-minute walk test
Measured: 12 weeks
Intensity and impact of fatigue
Evaluated by the Fatigue pictogram questionnaire, an ordinal scale composed of two questions graded in 5 captioned illustrations that assess the intensity (not at all tired, a little tired, moderately tired, very tired and extremely tired) and the impact of fatigue (I manage to do everything I normally do I do, I can do almost everything I usually do, I can do some of the things I usually do, I just do what I have to do and I can do very little).
Measured: 12 weeks
Secondary outcomes (2)
Spirometry
Number of patients with ventilatory disorder assessed by spirometry
Measured: 12 weeks
Quality of life assessment: Short Form-36 questionnaire
In this questionnaire, a score of zero corresponds to the worst general health status and the one hundred best health status.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start28 Mar 2021
- Primary completion31 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BRUNA THAYS SANTANA DE ARAÚJO, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767477
- Sponsor's protocol ID
- CR and TR
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol
- ClinicalTrials.gov ID
- NCT04767477
- Acronym / sponsor ID
- CR and TR
- Conditions
- Covid19, Exercise Tolerance, Quality of Life, Lung Function, Fatigue Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 23 Feb 2021 (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.
INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Thus, rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE: To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study. Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED RESULTS: This work will bring important information to the scientific community and health professionals, about the best forms of intervention and its repercussions on the surviving individuals of COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face-to-face rehabilitation and Telerehabilitation | Other | Other: Face-to-face rehabilitation, Other: TelerehabilitationThe Face-to-face rehabilitation and Telerehabilitation protocol will consist of flexibility exercises, aerobic and resistance training, with two sessions per week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of both genders;
- With a diagnosis of COVID-19 confirmed by a laboratory through RT-PCR means;
- Have to access to the internet and some device (smartphone, computer or notebook) that allows them to participate in the call centre.
Key exclusion criteria (2 listed)
- Individuals with orthopaedic or neurological diseases;
- Individuals with difficulties in understanding and that present psychological changes that make it difficult or impossible to understand the information presented.
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 |
|---|---|---|
| Face-to-face rehabilitationAerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions. | Other | Face-to-face rehabilitation and Telerehabilitation |
| TelerehabilitationThe telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance. | Other | Face-to-face rehabilitation and Telerehabilitation |
Primary outcome
Maximum functional capacity
Time frame: 12 weeks
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption
Submaximal functional capacity
Time frame: 12 weeks
Evaluated by the six-minute walk test
Intensity and impact of fatigue
Time frame: 12 weeks
Evaluated by the Fatigue pictogram questionnaire, an ordinal scale composed of two questions graded in 5 captioned illustrations that assess the intensity (not at all tired, a little tired, moderately tired, very tired and extremely tired) and the impact of fatigue (I manage to do everything I normally do I do, I can do almost everything I usually do, I can do some of the things I usually do, I just do what I have to do and I can do very little).
2 secondary outcomes
Spirometry
Time frame: 12 weeks
Quality of life assessment: Short Form-36 questionnaire
Time frame: 12 weeks
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 5 Oct 2021.
- 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 Face-to-face rehabilitation and Telerehabilitation in people with Covid19 and Exercise Tolerance, run by Universidade Federal de Pernambuco 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 2 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 5 Oct 2021. 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?
Maximum functional capacity (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 5 Oct 2021.