N/A
Completed N=37
Arthritis Pilot for Preserving Muscle While Losing Weight
Source: ClinicalTrials.gov NCT02239939 ↗Enrolled (actual)
37
Serious AEs
10.8%
Results posted
Jan 2018
Primary outcomePrimary: Change in Lean Mass Measured by DXA — -2.9; -2.3 Kg
Summary
The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults.
Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lean Mass Measured by DXA |
-2.9; -2.3 | — |
| SECONDARY Change in Hip Bone Density |
-6.1; -18.7 | — |
| SECONDARY Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS) |
15.3; 12.3 | — |
Eligibility Criteria
Inclusion Criteria
- BMI=30-40 kg/m2; Wt 14 drinks/wk),
- Smoker (>1 cigarette/d or 4/wk within yr),
- Evidence of cognitive impairment (MoCA score 125 mg/dl) or Hypertriglyceridemia (TG>400 mg/dl),
- Osteoporosis (T-score 160/90 mmHg) or abnormal kidney or liver tests per Medical Director discretion,
- Self- reported hepatitis B or C,
- Severe anemia (Hb<10 g/100 ml),
- Past or current uncontrolled endocrine/metabolic disease, neurological or hematological disease, fibromyalgia, chronic pulmonary disease, hyperparathyroidism, rheumatoid arthritis, unstable angina, MI, cardiac surgery within 3 months,
- Cancer requiring treatment in past year except non-melanoma skin cancers,
- Regular use of medications that may influence body weight, hormones, weight loss medications, bone remodeling medication, prior use of medications that affect bone, insulin-dependent,
- Unable to tolerate vest run-in.
Data sourced from ClinicalTrials.gov (NCT02239939). 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. Informational only — not medical advice.