Time Course Adaptations Using Deuterated Creatine (D3Cr) Method

Completed · Not applicable

Conditions studied: Sarcopenia

In brief

The pilot study is to assess the feasibility of using a new method to measure muscle mass called Deuterated Creatine (D3Cr) method and thereby understand the role of muscle mass on functional outcomes in older adults.

Key facts

Study ID: NCT03573583
Run by: University of Florida
People needed: 21
Starts: 2019-02-01
Expected to finish: 2020-08-01
Last updated by the study team: 2024-07-03

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

men and women aged 70 or greater
at high risk for mobility disability based on lower extremity functional limitations measured by Short Physical Performance battery (SPPB) with a score ≤ 8 out of 12
could safely participate in the resistance training intervention as determined by medical history and physical examination.
willing to give informed consent to be randomized to either the resistance training group or successful aging heath education comparison group and willing to follow the study protocol

You may not qualify if…

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
Myocardial infarction, major heart surgery, stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months
Lung disease requiring either oral or injected steroids, or the use of supplemental oxygen
Short, portable mental status questionnaire with 3 or more errors
Severe arthritis (either osteoarthritis or rheumatoid arthritis) that severely limits mobility
Severe lower back or shoulder pain that can worsen with weight lifting exercises.
Cancer requiring treatment in the past 1 year (Melanomas excluded)
Any present or recent history of severe psychiatric illness including depression that might preclude providing informed consent, safe participation, or compliance (self-report and investigator judgement
Development of chest pain or severe shortness of breath on the 400 m self-paced walk test
Parkinson's disease or other serious neurological disorders; renal disease requiring dialysis; other illness of such severity that life expectancy is considered to be less than 12 months
Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
Current consumption of more than 14 alcoholic drinks per week
Uncontrolled hypertension (systolic blood pressure > 200 mm Hg and/or diastolic blood pressure >110 mm Hg)
Currently on testosterone, Dehydroepiandrosterone (DHEA), or anabolic steroids.
Undergoing physical therapy involving the lower extremities
Currently enrolled in another randomized trial involving a pharmaceutical or lifestyle intervention. Observational studies are permitted
Participation in progressive resistance exercise regimen ( ≥1 day/week) within the previous 6 months prior to screening.
Weight change (intentional or not) over the last 6 months of > 5% of body or plan to lose or gain weight during the study
Any other cardiovascular, pulmonary, orthopedic, neurologic, or other conditions that in the opinion of the local clinician would preclude participation and successful completion of the protocol
Temporary Exclusion Criteria:
Recent bacterial/viral infection (e.g. pneumonia) (< 2 weeks);
Acute febrile illness in past 2 months;
Severe hypertension, e.g., SBP > 200 mm Hg, DBP > 110 mm Hg
Major surgery or fracture or hip/knee replacement (< 6 months);
Hospitalization within the last 6 months ( Not ER visits)

Where it is running

UF Health at the University of Florida — Gainesville, Florida, United States
UF Institute on Aging Clinical and Translational Research Building — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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