Status:
COMPLETED
Arthritis Pilot for Preserving Muscle While Losing Weight
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Medifast, Inc.
Conditions:
Obesity
Osteoarthritis
Eligibility:
All Genders
65-79 years
Phase:
NA
Brief 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...
Detailed Description
The loss of muscle mass and bone density during weight loss is partially attributed to the decrease in mechanical stress on these tissues as weight is reduced. As a result, performing exercises that e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02239939
Start Date
October 1 2014
End Date
January 1 2016
Last Update
March 9 2018
Active Locations (1)
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1
Wake Forest Baptist Health Sticht Center on Aging
Winston-Salem, North Carolina, United States, 27157