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

NCT02889146 | Completed

• 1 other identifier: deborass
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Muscle Weakness

Keywords

Intensive Care Units; Physical Therapy Specialty; Critical illness; Muscle weakness; Bed rest

Outcome Measures

Primary Outcomes (1)

• Functional status

  Ability to perform daily living activities assessed by Barthel Index

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

Secondary Outcomes (11)

• Level of physical activity during the whole intensive care unit stay

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

• Pulmonary function

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

• Maximum inspiratory pressure

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

• Peripheral muscle strength

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

• Electromyography muscle activity

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional Physical Therapy: motor physical therapy delivered by the intensive care unit physical therapists, according to his own criteria, without following any protocol. Respiratory therapy.

Other: Conventional Physical Therapy; Other: Respiratory therapy

Protocol group

EXPERIMENTAL

Early and progressive mobilization program: motor physical therapy delivered by a trained physical therapist according to the mobilization protocol, in which patient progress according to his performance. Respiratory therapy.

Other: Early and progressive mobilization program; Other: Respiratory therapy

Interventions

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.

Control group

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.

Protocol group

Respiratory therapy OTHER

Respiratory therapy according to the service routine.

Control group; Protocol group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05360-000, Brazil

Location

Related Publications (2)

• Gomes TT, Schujmann DS, Fu C. Rehabilitation through virtual reality: physical activity of patients admitted to the intensive care unit. Rev Bras Ter Intensiva. 2019 Oct-Dec;31(4):456-463. doi: 10.5935/0103-507X.20190078.

  PMID: 31967219 DERIVED

• Schujmann DS, Lunardi AC, Fu C. Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 May 10;19(1):274. doi: 10.1186/s13063-018-2641-4.

  PMID: 29747662 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscle Weakness

Interventions

Respiratory Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Carolina Fu, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: September 5, 2016
• Study Start: February 1, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

BR (1)