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

NCT05402007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

OTHER

Center-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:

OTHER

Home-based Intervention

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 & Collaborators

  • Centro Universitário Augusto Motta

    lead OTHER

Principal Investigators

  • Ana Carolina Sebastião da Silva · Centro Universitário Augusto Motta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2025-12-12
Completion
2026-04-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402007 on ClinicalTrials.gov