Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT01542892
Eligibility Criteria:
Inclusion Criteria:
1. Male \& Female ≥ 70 yrs
2. Community dwelling
3. Short Physical Performance Battery ≤ 9
4. Willingness to be randomized and come to the laboratory for 6 months
5. Body Mass Index \< 35
6. Mini-Mental State Examination \>=24
7. Serum 25 (OH) D (22.5 -50 nmol/l)
8. Having obtained his/her informed consent
9. Able to complete 400 M walk within 15 minutes
Exclusion Criteria:
* • Acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician
* Current regular use (\> 1 per week) of high protein oral nutritional supplements (eg: Boost, Exceed etc…)
* Current use of Vitamin D supplements, \>800 IU/day
* Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure.
* Upper or lower extremity fracture in previous 6 months.
* Hemoglobin \< 10 g/dL, Estimated GFR \< 30 mL/min/1.73 m2
* Uncontrolled hypertension (\>150/90 mm Hg).
* Neuromuscular diseases and drugs which affect neuromuscular function; severe progressive, degenerative neurologic disease
* Hormone replacement therapy
* Insulin-dependent diabetes mellitus
* Milk protein allergy
* Major surgery in the past 6 months (requiring general anesthesia)
* Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia)
* Excessive alcohol use (\>14 drinks per wk)
* Participation in moderate intensity physical activity \> 20 minutes/week
* Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
* Severe visual impairment (if it precludes completion of assessments and/or intervention)
* Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; wheelchair bound
* 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)
* Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
* Patient who cannot be expected to comply with treatment, as decided by the Principal Investigator and study physician.
* Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site Principal Investigator and/or study physician.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01542892
Study Brief:
Protocol Section:
NCT01542892