Covid19NCT04751630
Effects of COVID-19 Hospitalization on Physical Performance
A study testing Therapeutic Exercise in people with Covid19 and Physical Disability, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Physical Disability
- What is being tested?
- Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Have been diagnosed COVID-19 positive at the time of hospital admission.
- Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
- Be able to read the informed consent form and understand the objectives and conduct of the study.
Who cannot join
- Diagnosed neurological or psychiatric disease.
- Contraindications to physical exercise.
- Failure to give informed consent for the study.
- Unavailability to perform the ET program twice a week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.
Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.
The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.
Read more
Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.
Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.
- Conditions
- Covid19, Physical Disability
- Being tested
- Therapeutic Exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseOther
Online and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise group | Experimental | The study participants corresponding to the Therapeutic Exercise (ET) intervention group will follow the prescriptions given to them by their primary care physician. In addition, and as the main part of the intervention, they will undergo a six-week ET program with two sessions per week, for a total of 12 sessions. Full participation in 10 sessions will be necessary to be included in the ET group during the statistical analysis. Each session will be one hour long. The sessions will be given and supervised by a physiotherapist expert in therapeutic exercise prescription through the online modality. Receives: Other: Therapeutic Exercise |
| Control group | No intervention | Study participants in the control group will follow the prescriptions given to them by their primary care physician and will receive a weekly call to assess their recovery. At the end of the study follow-up, when their participation in the study as a control group ends, participants in this group will be offered to participate in the structured ET program to be carried out by the ET group. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb strength change
handgrip strength test
Measured: Change from Baseline upper limb strength at 6 weeks
Secondary outcomes (4)
Physical Performance change
Short Physical Performance Battery test
Measured: Change from Baseline physical performance at 6 weeks
Walking speed change
4 meters walking speed
Measured: Change from Baseline walking speed at 6 weeks
lower limb strength change
5 times sit and reach test
Measured: Change from Baseline lower limb strength at 6 weeks
Fraility change
FRAIL scale
Measured: Change from Baseline fraility at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Jun 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Pérez Bellmunt, Universitat Internacional de Catalunya
- Investigators
- Albert Pérez-Bellmunt, PhD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751630
- Sponsor's protocol ID
- CBAS-21-22
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.
- ClinicalTrials.gov ID
- NCT04751630
- Acronym / sponsor ID
- CBAS-21-22
- Conditions
- Covid19, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 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.
Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.
The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.
Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.
Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise group | Experimental | Other: Therapeutic ExerciseThe study participants corresponding to the Therapeutic Exercise (ET) intervention group will follow the prescriptions given to them by their primary care physician. In addition, and as the main part of the intervention, they will undergo a six-week ET program with two sessions per week, for a total of 12 sessions. Full participation in 10 sessions will be necessary to be included in the ET group during the statistical analysis. Each session will be one hour long. The sessions will be given and supervised by a physiotherapist expert in therapeutic exercise prescription through the online modality. |
| Control group | No intervention | –Study participants in the control group will follow the prescriptions given to them by their primary care physician and will receive a weekly call to assess their recovery. At the end of the study follow-up, when their participation in the study as a control group ends, participants in this group will be offered to participate in the structured ET program to be carried out by the ET group. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Have been diagnosed COVID-19 positive at the time of hospital admission.
- Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
- Be able to read the informed consent form and understand the objectives and conduct of the study.
Key exclusion criteria (4 listed)
- Diagnosed neurological or psychiatric disease.
- Contraindications to physical exercise.
- Failure to give informed consent for the study.
- Unavailability to perform the ET program twice a week.
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 |
|---|---|---|
| Therapeutic ExerciseOnline and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist. | Other | Therapeutic Exercise group |
Primary outcome
Upper limb strength change
Time frame: Change from Baseline upper limb strength at 6 weeks
handgrip strength test
4 secondary outcomes
Physical Performance change
Time frame: Change from Baseline physical performance at 6 weeks
Walking speed change
Time frame: Change from Baseline walking speed at 6 weeks
lower limb strength change
Time frame: Change from Baseline lower limb strength at 6 weeks
Fraility change
Time frame: Change from Baseline fraility at 6 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 11 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Albert Pérez-Bellmunt, PhD study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise in people with Covid19 and Physical Disability, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 4 inclusion and 4 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 11 Mar 2022. 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 Spain. 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?
Upper limb strength change (time frame: Change from Baseline upper limb strength at 6 weeks). 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 11 Mar 2022.