ExercisesNCT05402007
Effects of Cardiopulmonary Rehabilitation in Participants With Post-Intensive Care Syndrome.
A study testing Center-based rehabilitation and Home-based Intervention in people with Exercises and Pulmonary Rehabilitation, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial summary
Survivors of prolonged critical illness may develop post-intensive care syndrome, with reduced respiratory and peripheral muscle function and exercise capacity. This trial compared a home-based rehabilitation programme delivered through a self-explanatory workbook with weekly telephone monitoring against centre-based… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercises, Pulmonary Rehabilitation, Post-Intensive Care Syndrome (PICS)
- What is being tested?
- Center-based rehabilitation and Home-based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Jul 2023to 20 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged after more than seven days of intensive care, between three and six months from hospital discharge;
- Both sexes;
- Over 18 years old and under 65 years old.
Who cannot join
- Need for supplemental home oxygen;
- Motor or neurological or cognitive alteration that contraindicates the participation in the cardiopulmonary rehabilitation program.
- Persistence of clinical signs of deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Fisiatria e Reabilitação da Polícia Militar- RJ
Rio de Janeiro, Rio de Janeiro, 21073-460
About this study
Official title: Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in Post-Intensive Care Syndrome: Clinical and Randomized Trial
Survivors of prolonged critical illness may develop post-intensive care syndrome, with reduced respiratory and peripheral muscle function and exercise capacity. This trial compared a home-based rehabilitation programme delivered through a self-explanatory workbook with weekly telephone monitoring against centre-based supervised rehabilitation.
The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and functional status.
Read the detailed description
This is a randomized, controlled, assessor-blind treatment trial with a 1:1 allocation ratio.
Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient rehabilitation center. The participants will be adults (≥18 years and ≤ 65 years), who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged after, between three and six months from hospital discharge between 2023 to 2025.
Intervention and comparison:
This study will be divided into three groups: control group(standard rehabilitation), face-to-face home intervention group. Both groups will be evaluated before and after the study period. Physical functions and functional capacity will be evaluated.
After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home.
The intervention groups should perform the exercises in the period of 12 weeks, 3 times a week, totaling 36 intervention sessions.
Blinding The allocation sequence was generated before the start of enrolment. The assessor who performed the baseline clinical and functional evaluation was unaware of the arm to which the participant had been allocated, because allocation was disclosed only after that evaluation had been completed and recorded. Participants then followed the allocation already generated. The physiotherapists who delivered the rehabilitation sessions applied the assigned protocol and were not informed of the outcomes under investigation or of the hypothesis of the trial, so that their conduct of the sessions could not be oriented towards any particular outcome; they could not be blinded to the modality itself, since the two programmes are delivered in different settings. The assessor who performed the 12-week evaluation was unaware of the arm to which the participant had been allocated. Participants could not be blinded to the modality they received. State whether the baseline and 12-week assessments were performed by different assessors, what measures prevented participants from revealing their allocation during the 12-week assessment, and whether the statistician was unaware of allocation during the analysis.
Data monitoring
The trial is overseen by a data monitoring committee constituted at the institution to oversee its randomized clinical trials. The committee comprises five members, none of whom is a member of the study team or takes part in recruitment, delivery of the interventions, outcome assessment or data analysis. One member is the chair of the institutional Research Ethics Committee.
- Conditions
- Exercises, Pulmonary Rehabilitation, Post-Intensive Care Syndrome (PICS), Home-based Rehabilitation
- Being tested
- Center-based rehabilitation, Home-based Intervention
- Keywords
- Pulmonary Rehabilitation, Exercises, Home-based Rehabilitation, Non-inferiority trial, Randomized clinical trial
- Medical subject headings
- Motor Activity, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-based rehabilitationOther
Both programmes lasted 12 weeks, with three sessions per week and a total of 36 sessions, and both were designed to address muscle strength, muscular fatigue and functional capacity. The centre-based protocol was developed from previously published clinical trial protocols with those objectives. It was delivered in a dedicated outpatient clinic by a physiotherapist specialized in the programme, in groups of up to three participants, always in the morning. Each session lasted approximately 80 to 90 minutes and comprised: warm-up on a treadmill or cycle ergometer (5 min); aerobic training on a treadmill or cycle ergometer (30 to 45 min); loaded strength and muscular-endurance training of the upper and lower limbs (30 min), addressing the muscle groups used in daily activities through frontal and lateral raises, flexion and extension, functional diagonal movements, squats, and dorsiflexion and plantar flexion, performed as three sets of each exercise with a 1-minute interval between sets:
Home-based InterventionOther
The home-based protocol comprised breathing exercises, stretching, muscle strengthening, balance and aerobic training, illustrated in a booklet. The booklet was delivered after the baseline evaluation and its execution was explained by a physiotherapist specialized in rehabilitation sciences in a face-to-face session. Every week the same professional made telephone contact to answer questions about the training, verify the regularity of the exercises and, where necessary, give advice. The intervention evaluated is therefore this combined package of booklet, initial instruction and weekly telephone monitoring. All exercises were designed to be simple and of low risk, at no cost to participants, and no equipment was provided; participants were advised to exercise preferably in the morning and in comfortable clothing. Each session lasted approximately 80 to 90 minutes and comprised: pursed-lip breathing, consisting of nasal inspiration with the mouth closed followed by expiration through
| Study group | Role | What they receive |
|---|---|---|
| Center-based rehabilitation(Control) | Active comparator | The face-to-face intervention group will perform pulmonary rehabilitation at the Center-based rehabilitation. Receives: Other: Center-based rehabilitation |
| Home-based rehabilitation (Experimental) | Active comparator | The home-based intervention group will carry out home intervention through a self-explanatory exercise booklet. Receives: Other: Home-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
By 6MWD following the ERS/ATS field walking test
Measured: 12 weeks
Respiratory muscle function (MIP)
MIP will be measure according to the ATS/ERS statement on respiratory muscle testing
Measured: 12 weeks
Peripheral muscle function
Quadriceps strength will be assessed by a one-repetition-maximum (1-RM) test on an extension chair and quadriceps endurance will be assessed after 30 minutes of rest as the time for which a load corresponding to 40% of the 1-RM could be sustained isometrically until task failure (isometric endurance, in seconds)
Measured: 12 weeks
Daily living activity
It will be evaluated by the Post-COVID Function Scale(PCFS)
Measured: 12 weeks
Secondary outcomes (1)
Quality of life improvement
The assessment of quality of life will be carried out using a generic instrument of 36 items, validated in Brazil and called the SF-36 (Short Form Health Survey).
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 posted2 Jun 2022
- Study start17 Jul 2023
- Primary completion12 Dec 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExercisesStudies 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
- Model description
- Two pre-post assessment groups: Center-based rehabilitation(control)/face-to-face intervention/self-performed home-based rehabilitation (intervention)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carolina Sebastião da Silva, Centro Universitário Augusto Motta
- Investigators
- Ana Carolina Sebastião da Silva, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402007
- Sponsor's protocol ID
- NTC20457
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2022
- Last updated
- 27 Jul 2026
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in Post-Intensive Care Syndrome: Clinical and Randomized Trial
- ClinicalTrials.gov ID
- NCT05402007
- Acronym / sponsor ID
- NTC20457
- Conditions
- Exercises, Pulmonary Rehabilitation, Post-Intensive Care Syndrome (PICS), Home-based Rehabilitation
- Keywords
- Pulmonary Rehabilitation, Exercises, Home-based Rehabilitation, Non-inferiority trial, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 2 Jun 2022 (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.
Survivors of prolonged critical illness may develop post-intensive care syndrome, with reduced respiratory and peripheral muscle function and exercise capacity. This trial compared a home-based rehabilitation programme delivered through a self-explanatory workbook with weekly telephone monitoring against centre-based supervised rehabilitation.
The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and functional status.
Detailed description
This is a randomized, controlled, assessor-blind treatment trial with a 1:1 allocation ratio.
Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient rehabilitation center. The participants will be adults (≥18 years and ≤ 65 years), who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged after, between three and six months from hospital discharge between 2023 to 2025.
Intervention and comparison:
This study will be divided into three groups: control group(standard rehabilitation), face-to-face home intervention group. Both groups will be evaluated before and after the study period. Physical functions and functional capacity will be evaluated.
After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home.
The intervention groups should perform the exercises in the period of 12 weeks, 3 times a week, totaling 36 intervention sessions.
Blinding The allocation sequence was generated before the start of enrolment. The assessor who performed the baseline clinical and functional evaluation was unaware of the arm to which the participant had been allocated, because allocation was disclosed only after that evaluation had been completed and recorded. Participants then followed the allocation already generated. The physiotherapists who delivered the rehabilitation sessions applied the assigned protocol and were not informed of the outcomes under investigation or of the hypothesis of the trial, so that their conduct of the sessions could not be oriented towards any particular outcome; they could not be blinded to the modality itself, since the two programmes are delivered in different settings. The assessor who performed the 12-week evaluation was unaware of the arm to which the participant had been allocated. Participants could not be blinded to the modality they received. State whether the baseline and 12-week assessments were performed by different assessors, what measures prevented participants from revealing their allocation during the 12-week assessment, and whether the statistician was unaware of allocation during the analysis.
Data monitoring
The trial is overseen by a data monitoring committee constituted at the institution to oversee its randomized clinical trials. The committee comprises five members, none of whom is a member of the study team or takes part in recruitment, delivery of the interventions, outcome assessment or data analysis. One member is the chair of the institutional Research Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two pre-post assessment groups: Center-based rehabilitation(control)/face-to-face intervention/self-performed home-based rehabilitation (intervention)
| Arm | Type | Receives |
|---|---|---|
| Center-based rehabilitation(Control) | Active comparator | Other: Center-based rehabilitationThe face-to-face intervention group will perform pulmonary rehabilitation at the Center-based rehabilitation. |
| Home-based rehabilitation (Experimental) | Active comparator | Other: Home-based InterventionThe home-based intervention group will carry out home intervention through a self-explanatory exercise booklet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged after more than seven days of intensive care, between three and six months from hospital discharge;
- Both sexes;
- Over 18 years old and under 65 years old.
Key exclusion criteria (3 listed)
- Need for supplemental home oxygen;
- Motor or neurological or cognitive alteration that contraindicates the participation in the cardiopulmonary rehabilitation program.
- Persistence of clinical signs of deep vein thrombosis
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 |
|---|---|---|
| Center-based rehabilitationBoth programmes lasted 12 weeks, with three sessions per week and a total of 36 sessions, and both were designed to address muscle strength, muscular fatigue and functional capacity. The centre-based protocol was developed from previously published clinical trial protocols with those objectives. It was delivered in a dedicated outpatient clinic by a physiotherapist specialized in the programme, in groups of up to three participants, always in the morning. Each session lasted approximately 80 to 90 minutes and comprised: warm-up on a treadmill or cycle ergometer (5 min); aerobic training on a treadmill or cycle ergometer (30 to 45 min); loaded strength and muscular-endurance training of the upper and lower limbs (30 min), addressing the muscle groups used in daily activities through frontal and lateral raises, flexion and extension, functional diagonal movements, squats, and dorsiflexion and plantar flexion, performed as three sets of each exercise with a 1-minute interval between sets: | Other | Center-based rehabilitation(Control) |
| Home-based InterventionThe home-based protocol comprised breathing exercises, stretching, muscle strengthening, balance and aerobic training, illustrated in a booklet. The booklet was delivered after the baseline evaluation and its execution was explained by a physiotherapist specialized in rehabilitation sciences in a face-to-face session. Every week the same professional made telephone contact to answer questions about the training, verify the regularity of the exercises and, where necessary, give advice. The intervention evaluated is therefore this combined package of booklet, initial instruction and weekly telephone monitoring. All exercises were designed to be simple and of low risk, at no cost to participants, and no equipment was provided; participants were advised to exercise preferably in the morning and in comfortable clothing. Each session lasted approximately 80 to 90 minutes and comprised: pursed-lip breathing, consisting of nasal inspiration with the mouth closed followed by expiration through | Other | Home-based rehabilitation (Experimental) |
Primary outcome
Functional Capacity
Time frame: 12 weeks
By 6MWD following the ERS/ATS field walking test
Respiratory muscle function (MIP)
Time frame: 12 weeks
MIP will be measure according to the ATS/ERS statement on respiratory muscle testing
Peripheral muscle function
Time frame: 12 weeks
Quadriceps strength will be assessed by a one-repetition-maximum (1-RM) test on an extension chair and quadriceps endurance will be assessed after 30 minutes of rest as the time for which a load corresponding to 40% of the 1-RM could be sustained isometrically until task failure (isometric endurance, in seconds)
Daily living activity
Time frame: 12 weeks
It will be evaluated by the Post-COVID Function Scale(PCFS)
1 secondary outcome
Quality of life improvement
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 27 Jul 2026.
- 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.
Ana Carolina Sebastião da Silva principal investigator
Centro Universitário Augusto Motta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-based rehabilitation and Home-based Intervention in people with Exercises and Pulmonary Rehabilitation, 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 3 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 27 Jul 2026. 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?
Functional Capacity (time frame: 12 weeks). The study lists 4 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 27 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.