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Completed

NCT Number: NCT02889146

Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients

The purpose of this study is to verify if a protocol of early and progressive mobility which includes the use of technology is able to increase the level of physical activity and improve functionality and respiratory and muscular function of Intensive Care Unit patients compared with conventional Physical Therapy.

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Key information

Conditions

Critical Illness Disease Attributes Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo

São Paulo, 05360-000, Brazil

About this study

The evolution of treatment in the Intensive Care Unit (ICU) has increased the survival and morbidity post hospital. Functional disability in these patients has its main factor in the weakness and loss of muscle mass, which is the major complications reported by these patients. The most negative result in long-term post ICU is the impact on quality of life and functional decline due to muscle disorders and fitness. This is achieved by the period of inactivity and prolonged rest, leading to losses and changes in various body systems. Given these facts, interventions for greater mobility in bed and out of it are very important. Early mobility programs has proved beneficial, however, as in other types of rehabilitation, the exercises should be prescribed with its specific characteristics, including the intensity. However, little has been described in the researches abut the activity level in the ICU, and using a quantitative measure. The use of technology seems to facilitate the offering of this type of therapy, supplying the limitations. Therefore, there are little evidences about these topics and randomized controlled studies to investigate these factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • admitted to the Emergency Intensive Care Unit of Clinical Hospital, Medical School, University os Sao Paulo
  • inspired oxygen fraction ≤ 60%
  • positive end expiratory pressure ≤ 10 points
  • peripheral oxygen saturation ≥ 90%
  • respiratory rate ≤ 35
  • without cardiac arrhythmia or acute ischaemia
  • heart rate > 50 bpm and < 140 bpm
  • without high or raising dose of vasoactive drugs
  • mean body pressure > 60 mmHg and < 120 mmHg
  • without active bleeding
  • without prescribed bedrest

Exclusion criteria

  • transference from other hospital
  • diagnosis of neurological disorders
  • intensive care unit stay < 4 days
  • contraindication to mobilization

Treatment and study plan

Conventional physical therapy

Other

Control group will receive respiratory therapy according to the service routine and conventional physical therapy. Conventional physical therapy will be offered by the hospital physical therapists, according to their own criteria. Consists of passive, assisted and resisted mobilization, positioning in bed, transferring to bedside or chair, orthostatism and deambulation, however without a definition of a protocol. The physical therapist will be responsible for the choice of the techniques employed in each session. There will be no previous definition of the next sessions. No technology equipment will be used in this group, since they are not available in the routine care.

Early and progressive mobilization program

Other

Protocol group will receive respiratory therapy according to the service routine and motor physical therapy according to the program of early and progressive mobilization. Patients will receive the program once daily during the intensive care unit stay, offered by a trained physical therapist, at the adequate level according to the level of consciousness and muscle strength. The program contains by techniques for muscle length and muscle strength maintenance or gain, aerobic exercises, exercises for gait rehabilitation and cognitive components. Patient will progress to the next level of the protocol completing the previous level. Technology equipment available: functional electrical stimulation device, dumbbells, cycle ergometer, fixed walker, ambulation assistive device and video game.

Respiratory therapy

Other

Respiratory therapy according to the service routine.

Primary outcomes

  1. Functional status

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Ability to perform daily living activities assessed by Barthel Index

Secondary outcomes

  1. Level of physical activity during the whole intensive care unit stay

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Level of physical activity measured by an accelerometer

  2. Pulmonary function

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Pulmonary function assessed by a spirometer

  3. Maximum inspiratory pressure

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Maximum inspiratory pressure measured by an specific equipment

  4. Peripheral muscle strength

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Muscle strength assessed by hand grip dynamometer

  5. Electromyography muscle activity

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Quadriceps femoris electric activity assessed by surface electromyography

  6. Muscle function and mobility

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Test by Time up and Go

  7. Intensive care unit length of stay

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Count of the number of days spent at the intensive care unit

  8. Correlation between physiological variables and the level of physical activity

    Time frame: At the time of discharge from the ICU, at least 4 days after admission.

    Correlation between the physiological variables collected during the study and the level of physical activity measured by the accelerometer

  9. ICU mobility Scale

    Time frame: Through study completion, an average of 2 weeks

    Measure of mobility milestones in critically ill patients.

  10. Long term follow up

    Time frame: After three months and one year of discharge

    Longer-term follow-up for functional status by Barthel Index after three months and one year of discharge

  11. Level of activity by Perceived Exertion

    Time frame: approximately 40 minutes after therapy, immediately after the end of the protocol

    Level of exercise by Perceived Exertion by Borg Rating of Perceived Exertion Scale

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Using a Progressive Mobility Program and Technology to Increase the Level of Physical Activity and Its Benefits in Respiratory, Muscular System and Functionality of ICU Patients: a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Nov 29, 2018

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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