Arthritis Pilot for Preserving Muscle While Losing Weight

Completed · Not applicable

Conditions studied: Obesity, Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02239939

Run by

Wake Forest University Health Sciences

People needed

37

Starts

2014-10-01

Expected to finish

2016-01-01

Last updated by the study team

2018-03-09

Who can join

Age: 65 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI=30-40 kg/m2; Wt<135 kg,
• self- reported MD diagnosis of osteoarthritis
• No evidence of clinical depression or other contraindications for participation in voluntary weight loss,
• Sedentary lifestyle (<30 min, 3 d/wk of exercise),
• Able to provide own transportation to study visits and intervention,
• Not dependent on a cane or walker,
• Willing and able to consume meal replacement products,
• Not involved in other research study,
• Approved for participation by Medical Director,
• Willing to provide informed consent.

You may not qualify if…

• Weight loss or gain (±5%) in past 6 mos,
• Excessive alcohol use (> 14 drinks/wk),
• Smoker (>1 cigarette/d or 4/wk within yr),
• Evidence of cognitive impairment (MoCA score <22) or difficulty with hearing or vision that would interfere with study participation, Insulin-dependent or uncontrolled diabetes (FBG >125 mg/dl) or Hypertriglyceridemia (TG>400 mg/dl),
• Osteoporosis (T-score< -2.5 on hip or spine); Hip fracture, joint replacement, or spinal surgery in past 6 mos, or hyperkyphosis,
• Uncontrolled hypertension (BP>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.

Where it is running

• Wake Forest Baptist Health Sticht Center on Aging — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.