Resistance Training in Older Adults With Limitations in Mobility (TRANS2)

This is an interventional prevention trial for Mobility Limitation Read More

Inclusion Criteria:

1. Willing and able to sign the IRB approved informed consent form.
2. Community dwelling
3. Male or female subject ≥ 70 years at first contact.
4. The subject has a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive.
5. SPPB score ≤9.
6. The subject is able to complete >200 meters during the 6-min walk test without an assistive device (single straight cane is acceptable), or the help of another person.
7. Mini-Mental State Examination (MMSE) score >21.
8. Participates in moderate-intensity physical activity ≤20 minutes/week.
9. Subject agrees not to participate in another interventional or exercise study while participating in the present study, defined as signing the informed consent form, until completion of the last study visit.

Exclusion Criteria:

1. Nursing home resident
2. Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], and/or total bilirubin [TBil]) above 1.5 times the upper limit of normal at screening.
3. Any clinically significant abnormality following the study doctor's review of the physical examination, ECG and protocol defined clinical laboratory tests at screening.
4. Serious conduction disorder (eg, third-degree heart block), uncontrolled arrhythmia, or ST-segment depressions (>3 mm) on the ECG at screening.
5. Myocardial infarction, major heart surgery (i.e, valve replacement or bypass surgery), stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months prior to screening.
6. A pulse < 40 or > 100 bpm; mean systolic blood pressure >160 mm Hg ; mean diastolic blood pressure >100 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically) at screening.
7. Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
8. Hemoglobin (Hb) concentration below 10.0 g/dL at screening.
9. Approximately >20% weight loss in the previous 3 months prior to screening
10. Chronic medications introduced within 2 weeks prior to screening
11. Cancer requiring treatment currently or in the past 3 years (except primary non-melanoma skin cancer, carcinoma in situ or cancers that have an excellent prognosis such as early stage breast or prostate cancer)
12. Neurological conditions or neuromuscular diseases that cause impaired muscle function or mobility
13. Current diagnosis of schizophrenia, other severe psychotic disorders, or severe bipolar disorder.
14. Severe and/or uncontrolled medical conditions that could interfere with the study (e.g. severe neurological deficit after stroke, respiratory diseases requiring supplemental oxygen, infection, gastrointestinal disorder, uncontrolled pain, arthritis or any other non-stable illness) as judged by the study doctor that would prevent participation in a resistance training exercise program.
15. Cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, uncontrolled atrial fibrillation, presence of an implantable cardiac defibrillator, or uncontrolled angina).
16. Surgical procedure requiring general anesthesia within 2 months prior to screening, or a planned surgical procedure requiring general anesthesia during the study period
17. Subject is using any medicines, non-medical compounds, or dietary aids/food supplements to improve physical function or muscle mass that have not been at a stable dose for at least 4 weeks prior to screening and/or are anticipated to change dosing regimen during the study.
18. The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 5 ounces of wine or 1.5 ounce of spirits/hard liquor).
19. Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives whichever is longer, prior to the initiation of screening.
20. The subject has any other condition, which in the opinion of the Investigator, precludes the subject's participation in the trial.
21. Employee of the Astellas Group or vendors involved in the study.