Arthritis Pilot for Preserving Muscle While Losing Weight
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Obesity Weight Loss, Osteoarthritis (OA) |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 65 - 79 |
| Updated: | 4/17/2018 |
| Start Date: | October 2014 |
| End Date: | January 2016 |
Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis
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.
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.
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 enhance muscle and gravitational loading during the period of caloric
restriction usually diminishes the relative amount of muscle and bone loss for a given weight
loss, but these interventions do not fully prevent all muscle and bone loss.In addition,
conventional exercise training interventions often require expensive equipment, on-site
participation, and, ideally for older, obese adults, safety supervision by trained exercise
leaders. Moreover, the exercises performed may not fully translate into improvement in daily
tasks due to training specificity, and are not always tolerated or sustained, especially in
obese persons with OA. On the other hand, it is conceivable that treating the decrease in
mechanical load from weight loss by externally replacing lost weight via use of a weighted
vest may also be effective for reducing muscle and bone loss during caloric restriction. In
animal models, mechanisms regulating skeletal tissue structure and function respond in a
similar fashion to increases in actual or externally-added body mass. Also, research shows
that exercising while wearing weighted vests can improve bone density, muscle mass, and lower
extremity strength in older adults. However, no prior studies have examined the effects of
weighted vest use on muscle mass and bone density during a period of intentional weight loss.
The main objective of this pilot study is to assess feasibility (accrual, retention,
compliance) of daily use of a weighted vest during a diet intervention, to estimate the
variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A
controlled, randomized design will be used so we can obtain a realistic estimate of accrual
and an unbiased estimate of treatment efficacy.
A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with
x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10%
weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or
2) Progressive weighted vest use during normal daily activities (VEST).
decrease in mechanical stress on these tissues as weight is reduced. As a result, performing
exercises that enhance muscle and gravitational loading during the period of caloric
restriction usually diminishes the relative amount of muscle and bone loss for a given weight
loss, but these interventions do not fully prevent all muscle and bone loss.In addition,
conventional exercise training interventions often require expensive equipment, on-site
participation, and, ideally for older, obese adults, safety supervision by trained exercise
leaders. Moreover, the exercises performed may not fully translate into improvement in daily
tasks due to training specificity, and are not always tolerated or sustained, especially in
obese persons with OA. On the other hand, it is conceivable that treating the decrease in
mechanical load from weight loss by externally replacing lost weight via use of a weighted
vest may also be effective for reducing muscle and bone loss during caloric restriction. In
animal models, mechanisms regulating skeletal tissue structure and function respond in a
similar fashion to increases in actual or externally-added body mass. Also, research shows
that exercising while wearing weighted vests can improve bone density, muscle mass, and lower
extremity strength in older adults. However, no prior studies have examined the effects of
weighted vest use on muscle mass and bone density during a period of intentional weight loss.
The main objective of this pilot study is to assess feasibility (accrual, retention,
compliance) of daily use of a weighted vest during a diet intervention, to estimate the
variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A
controlled, randomized design will be used so we can obtain a realistic estimate of accrual
and an unbiased estimate of treatment efficacy.
A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with
x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10%
weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or
2) Progressive weighted vest use during normal daily activities (VEST).
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.
We found this trial at
1
site
Click here to add this to my saved trials
