Exercises, Home-based Rehabilitation, Post-Intensive Care Syndrome (PICS), Pulmonary Rehabilitation
Conditions
Keywords
Pulmonary Rehabilitation, Exercises, Home-based Rehabilitation, Non-inferiority trial, Randomized clinical trial
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.
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.
Interventions
OTHERCenter-based rehabilitation
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:
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
Sponsors
Centro Universitário Augusto Motta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Two pre-post assessment groups: Center-based rehabilitation(control)/face-to-face intervention/self-performed home-based rehabilitation (intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity | 12 weeks | By 6MWD following the ERS/ATS field walking test |
| Respiratory muscle function (MIP) | 12 weeks | MIP will be measure according to the ATS/ERS statement on respiratory muscle testing |
| Peripheral muscle function | 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 | 12 weeks | It will be evaluated by the Post-COVID Function Scale(PCFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life improvement | 12 weeks | 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). |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORAna Carolina Sebastião da Silva
Centro Universitário Augusto Motta
Outcome results
None listed