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Completed

NCT Number: NCT01577927

Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients

Patients at high complexity with severe chronic diseases can require several admission in intensive care units (ICU) to overcome acute exacerbations by the use of assisted ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. These patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression.

Weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. Patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks.

When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually managed by GPs and by the hospital where he has been admitted to following re-exacerbations. The conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management.

A structured program of Home Rehabilitation could be a possible solution to this problem. Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.

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Key information

Conditions

Chronic Diseases Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Salvatore Maugeri

Lumezzane, Brescia, 25065, Italy

About this study

Patients referred to the Fondazione Salvatore Maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. Home care compares 2 arms: usual care vs physiotherapist (PT)-assisted care. Usual care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance, periodical in-hospital visit. The PT-assisted home care is supported by PT at least 2 times/month, autonomous 50 min physical activity/working day by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Few brief educational lessons by PT preceded the training activity. Every two weeks, PT calls the patient by phone for an educational reinforcement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life
  • Specific Inclusion Criteria : Score of general dependences < 19 according to the Critical Patients Autonomy Planning (CPAP) Scale

Exclusion criteria

  • Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.
  • Unstable patient conditions as daily variability of the blood arterial pressure >20%, arrhythmias, PaO2/FiO2 < 300, unsatisfactory respiratory pattern, haemoglobin < 7 g /dL, temperature > 38°C, presence of neurological or orthopaedic side effects, and recent embolisms from TVP. Refusal.

Treatment and study plan

Usual home care

Other

Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.

PT-assisted home rehabilitation

Behavioral

Patient performs 50 min physical activity/working day autonomously by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles.

Every two weeks, PT phones the patient for an educational reinforcement.

Primary outcomes

  1. Critical Patients Autonomy Planning (CPAP)

    Time frame: Changes from baseline and 4 weeks, and 6 months after home activity

    CPAP is a measure of dependency. CPAP was evaluated at three different time-points: at in-hospital admission (baseline), at discharge (patients are followed for the duration of their in-hospital stay, an expected average time of 4 weeks), and after 6 months of physical activity at home.

Secondary outcomes

  1. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

    Time frame: Changes from baseline and 4 weeks (average time), and 6 months after home activity

    Respiratory Functionality

  2. MRF 26

    Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity

    Quality of life evaluation.

  3. Likert Scale

    Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity

    Satisfaction for patient/caregiver

  4. Mortality

    Time frame: Changes between 3, 6 and 12 months post-discharge

    Clinical measure

  5. MRC Scale and/or dynamometer

    Time frame: Changes between baseline, discharge at 4 weeks, and 6 months after home activity

    Rehabilitative measure referring to muscles force

  6. 6-min walking test

    Time frame: Changes from baseline and discharge at 4 weeks, and 6 months after home activity

    Rehabilitative measure evaluating the effort tolerance.

  7. EuroQol

    Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity

    Quality of life evaluation

  8. Gussago Nursing Scale

    Time frame: Changes from baseline and 4 weeks, and 6 months after home activity

    Measure of dependency.

  9. Barthel Index

    Time frame: Changes from baseline and 4 weeks, and 6 months after home activity

    Measure of dependency.

  10. Pre-morbidity life-style (PLS)

    Time frame: Changes from baseline and 4 weeks, and 6 months after home activity

    Measure of dependency.

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Official study title

Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Acronym: UTIR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2012
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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