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Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT02787720
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
Shahid Beheshti University
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

Brief Summary:
A randomized controlled blinded study in patients treated for Acute Respiratory Distress Syndrome (ARDS) in the mixed medical-surgical intensive care units (ICU) of four academic teaching hospitals in Tehran, Iran were conducted to examine the effects of Varied Rehabilitation Techniques on Survivors of ARDS patients. Patients were randomized in the emergency department at the time of ICU admission to one of four groups labeled groups 1, 2, 3 and 4, respectively.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Tobacco; Use, Rehabilitation Other: Family centered empowerment model Other: Continuous care model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Varied Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
Study Start Date : December 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Family centered empowerment model
The Family-Centered Empowerment Model (FCEM)
Other: Family centered empowerment model
The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Perceived threat, Problem solving, Educational partnership, and Evaluation

Experimental: Continuous care model
The Continuous Care Model
Other: Continuous care model
The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Orientation, Sensitization, Control, and Evaluation




Primary Outcome Measures :
  1. Quality of life: The short form health survey questionnaire with 36 questions [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. The 14-Item Perceived Stress Questionnaire [ Time Frame: Five years ]

Other Outcome Measures:
  1. The Beck 20-Item state and 20-Item trait anxiety Questionnaires [ Time Frame: Five years ]
  2. the Barthel with 10 variables describing activities of daily living ( ADL) and mobility [ Time Frame: Five years ]
  3. The Kessler Psychological Distress Scale (K10) [ Time Frame: Five years ]
  4. The standardized 6MWT [ Time Frame: Five years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Informed consent
  • Willingness of designated family member or friend to participate
  • Has basic health literacy and can fill out questionnaire
  • Admitted to the ICU, (6) full code status
  • Met ARDS criteria

Exclusion Criteria:

  • Patients with any limitation of code status
  • Patients who were immobile prior to ICU admission
  • Patients who were received prior pulmonary rehabilitation
  • Patients who had a documented neurologic or psychiatric disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787720


Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Shahid Beheshti University
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Amir Vahedian-azimi, Postdoc Baqiyatallah Universiy of Medical Sciences
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Responsible Party: Amir Vahedian-Azimi, Dr, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT02787720    
Other Study ID Numbers: ARDS Rehabilitation
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University:
Acute Respiratory Distress Syndrome
Pulmonary Rehabilitation
Rehabilitation Plan
Rehabilitation Techniques
Survivor
Randomized Controlled Trial
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury