Please select the eligibility criteria that correspond to the clinical trial below.
Title: Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure
Brief Summary: Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant.

The investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care.

This study's primary objective is to determine whether standardized rehabilitation therapy will decrease hospital length of stay.

Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure.


Options:
A: Inclusion Criteria:

1. age 70 to 89 years; (2) summary score \<10 on the short physical performance battery (SPPB) (45% are \<8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.

   Exclusion Criteria:

   Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
   * Current consumption of more than 14 alcoholic drinks per week
   * Plans to relocate to out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
   * Self-reported inability to walk across a small room
   * The use of a walker to complete the 400 m walk and/or unable to complete the 400 m walk without sitting down or the help of another person
   * Another member of the household is a participant in the Life Study
   * Residence too far from the intervention site
   * Residence in a nursing home
   * Difficulty in communication with study personnel due to speech or hearing problems
   * Modified Mini-Mental State Exam (3MSE) score below the cutoff for education:

   African American, 9+ yrs 76, \<9 yrs 70; English Speaking Non-African American, 9+ yrs 80, \<9 yrs 76; Spanish Speaking, 9+ yrs 80, \<9 yrs 70
   * Participation in LIFE-Pilot study
   * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

   Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions

   • Severe arthritis (either osteoarthritis or rheumatoid arthritis)

   • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)

   • Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen

   • Development of chest pain or severe shortness of breath on a 400 m self-paced walk test

   • Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, use of a cardiac defibrillator or uncontrolled angina)

   • Parkinson's disease or other serious neurological disorder

   • Renal disease requiring dialysis

   • Other illness of such severity that life expectancy is considered to be less than 12 months

   • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site

   Temporary Exclusion Criteria

   • Uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg).

   • Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
   * Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
   * Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>3 mm) on ECG.
   * Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
   * Undergoing physical therapy or cardiopulmonary rehabilitation
   * Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
B: Inclusion Criteria:

* Age ≥ 18 years
* Mechanically ventilated via an Endotracheal tube or Bipap
* Lung Injury

Exclusion Criteria:

* Previously enrolled in TARGET STUDY
* Inability to walk without assistance prior to acute ICU illness (use of a cane or walker not exclusion)
* Cognitive impairment prior to acute ICU illness (non-verbal)
* Acute stroke
* Body mass index (BMI) \> 50
* Neuromuscular disease that could impair weaning
* Hip fracture, unstable cervical spine or pathological fracture
* Mechanically ventilated \> 80 hours
* Current hospitalization or transferring hospital stay \> 7 days
* Ineligible cancer treatment within the last 6 month
* Moribund
* Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission
* Other Research Study
C: Inclusion Criteria: 1) Aged 50 years or older at study entry. 2) Literacy in English language sufficient for understanding the study protocol and completing questionnaires. 3) Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?" 4) Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation. 5) Successful completion of tasks during run-in period, including 2 in-person appointments, 2 phone contacts, and 1 set of homework questionnaires. 6) A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study. 7) A score of 24 points or higher on the Folstein mini-mental status exam, administered by research personnel at entrance to run-in trial and again just prior to consent and enrollment in the main study.

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Exclusion Criteria: 1) Physical or medical condition prohibiting adherence to study protocol. Prospective participants must meet the American Heart Association guidelines225 for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment. 2) Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice? 3) Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the BRFSS classification226 system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) \>4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week. 4) Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease; Co-Investigator Dr. Muller will advise in questionable cases). 5) Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed. 6) Current use or forecasted need for antibiotic or antiviral medications (eg. prophylactic or suppressive therapy for chronic urinary tract infection, recurrent herpes, or other chronic infections. 7) Malignant disease (prospective participants' physicians to advise. Dr. Barrett to make final decision in questionable cases). 8) Function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). 9) Influenza vaccination (flu shots) within 6 months prior to enrollment. 10) True egg allergy or true allergic reaction to prior flu shot, either of which would have to include at least one of the following: a) large rash or swelling (more than 12 inches in diameter), b) any swelling in throat, c) any difficulty breathing, d) reaction with hospitalization, or e) anaphylaxis. Reactions that would NOT exclude people: a) local pain or swelling, b) fever, c) malaise, feeling lousy, or d) cold, flu or other infectious illness.
D: Inclusion Criteria:

* clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
* ≥ 18 years old
* able to provide their own informed consent

Exclusion Criteria:

* cognitive impairments
* inability to understand and co-operate
* bedridden or complete dependence on a wheelchair
* score \>2 in the CURB criteria
* presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)

Answer: B