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N/A N=21 Randomized Single-blind Basic Science

Time Course Adaptations Using Deuterated Creatine (D3Cr) Method

Sarcopenia

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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