Arthritis Pilot for Preserving Muscle While Losing Weight (APPLE)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Osteoarthritis
• Intervention / Treatment: Behavioral: Vest; Behavioral: Diet

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 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).

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sticht Center on Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vest + Diet; All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.	Behavioral: Vest; light weight, adjustable, vest to be worn underneath clothes that weight can be added to; Other Names: Hyperwear Vest Pro; Behavioral: Diet; Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.; Other Names: Medifast 4&2&1
Active Comparator: No Vest + Diet; All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.	Behavioral: Diet; Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.; Other Names: Medifast 4&2&1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hip Bone Density	Hip bone density as measured by DXA.	Basleine and 22 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Body weight	Baseline and 22 weeks
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Medifast, Inc.
• Investigators: Principal Investigator: Barbara J. Nicklas, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: older adults, body composition, weight loss, muscle mass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Obesity; Osteoarthritis
• Other Study ID Numbers: IRB00028928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No