N/A
N=21
Time Course Adaptations Using Deuterated Creatine (D3Cr) Method
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT03573583 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Muscle Mass — 3.47; 1.19 Kg — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resistance Training (Behavioral); Successful Aging (Behavioral)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Mass |
3.47; 1.19 | 0.03 sig |
| SECONDARY Appendicular Lean Mass (ALM) |
0.81; -0.23 | 0.009 sig |
| SECONDARY Lean Body Mass (LBM) |
1.10; -0.19 | 0.07 |
| SECONDARY Correlation Between Changes in Muscle Mass |
0.19 | 0.49 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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) ( 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)
Data sourced from ClinicalTrials.gov (NCT03573583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.