Please select the eligibility criteria that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


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:

* Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

Exclusion Criteria:

* secondary osteoporosis
* CVD-events including stroke
* Participation in other studies
* Medication with impact on bone during the last 2 years:

  * bisphosphonates
  * parathormone
  * strontium
  * HRT, anabolic steroids
  * calcitonin
  * natriumflourides
  * active Vit-D-metabolites
  * cortisone \> 5 mg/d
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake
C: Inclusion Criteria:

* 2 or more falls within 6 months prior to the beginning of the study
* Aged 60-85 years
* Able to walk for 5 minutes unassisted
* Adequate hearing and vision capabilities.
* Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

* Psychiatric co-morbidity
* Clinical diagnosis of dementia or other severe cognitive impairment (MMSE\<24)
* History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
* Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
* Unstable medical condition in the past 6 months
* Unable to comply with the training
* Interfering therapy
D: Inclusion Criteria:

* female
* age 70-80 years old
* lives at home independently
* has fallen at least once during the previous year
* no contraindication to exercise
* understands the procedures of the study
* has been informed of X-ray radiation doses of the DXA and pQCT investigations

Exclusion Criteria:

* moderate-to-vigorous exercise more than 2 hours per week
* regular use of vitamin D, or calcium + vitamin D supplements
* a recent fracture (during preceding 12 months)
* contraindication or inability to participate in the exercise program
* marked decline in the basic activities of daily living (ADL-test)
* cognitive impairments (Mini Mental State Examination, MMSE-test \< 18)
* persons with chronic disease conditions, such as Parkinson's disease

Answer: C