Effects of Cardiopulmonary Rehabilitation in Participants With Post-Intensive Care Syndrome.

NCT05402007 | Completed DMC

• 1 other identifier: NTC20457
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (4)

• Functional Capacity

  By 6MWD following the ERS/ATS field walking test

  12 weeks

• Respiratory muscle function (MIP)

  MIP will be measure according to the ATS/ERS statement on respiratory muscle testing

  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)

  12 weeks

• Daily living activity

  It will be evaluated by the Post-COVID Function Scale(PCFS)

  12 weeks

Secondary Outcomes (1)

• Quality of life improvement

  12 weeks

Study Arms (2)

Center-based rehabilitation(Control)

ACTIVE COMPARATOR

The face-to-face intervention group will perform pulmonary rehabilitation at the Center-based rehabilitation.

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.

Other: Home-based Intervention

Interventions

Center-based rehabilitation OTHER

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:

Center-based rehabilitation(Control)

Home-based Intervention OTHER

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

Home-based rehabilitation (Experimental)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Centro de Fisiatria e Reabilitação da Polícia Militar- RJ

Rio de Janeiro, Rio de Janeiro, 21073-460, Brazil

Location

MeSH Terms

Conditions

Motor Activity; postintensive care syndrome

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ana Carolina Sebastião da Silva

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree

Model Details: Two pre-post assessment groups: Center-based rehabilitation(control)/face-to-face intervention/self-performed home-based rehabilitation (intervention)

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: June 2, 2022
• Study Start: July 17, 2023
• Primary Completion: December 12, 2025
• Study Completion: April 20, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)