Obesity Clinical Trial
— APPLEOfficial title:
Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis
Verified date | February 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 79 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Health Sticht Center on Aging | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Medifast, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Body Weight | Body weight | Baseline and 22 weeks | |
Other | Changes in Lower Extremity Physical Function | SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. | Baseline and 22 weeks | |
Primary | Change in Lean Mass Measured by DXA | Lean body mass (Whole body and lower-extremity lean mass are used in total calculation). | Baseline and 22 weeks | |
Secondary | Change in Hip Bone Density | Hip bone density as measured by DXA. | Basleine and 22 weeks | |
Secondary | Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS) | Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where "0' equals no fatigue at all, and "5" equals extreme fatigue. | baseline and 22 weeks |
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