Muscle and Movement With Anti-Obesity Medications

Summary

The goal of this clinical trial is to learn about changes in body composition related to obesity medication use, and whether aerobic or resistance exercise training will impact these body composition changes. It will also provide information about whether aerobic or resistance exercise training has additional benefits on other health and fitness measurements. The main questions it aims to answer are:

* Is there a difference in the change in body composition (fat mass, lean mass, muscle mass, and bone content) between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in body weight and BMI between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in cardiorespiratory fitness between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in how much physical activity is completed between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in physical function between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in muscle strength between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in resting blood pressure between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in food intake between the standard medical care and the exercise conditions (aerobic training and resistance training)?
* Is there a difference in the change in health-related quality of life between the standard medical care and the exercise conditions (aerobic training and resistance training)?

Participants will:

* Participate in an intervention for a period of 6 months that involves being assigned to a no exercise/standard medical care condition, or a supervised exercise condition (aerobic training or resistance training).
* Visit the clinical before starting the study and at 6 months to complete study measurements of their body composition and other measurements to monitor their progress.
* Complete a brief monitoring session at weeks 6, 12, and 18 across the 6 months.
* Complete supervised exercise sessions at the research center 3x per week for 6 months (Participants in the exercise groups only: aerobic training or resistance training).

Conditions

• Obesity and Overweight

Interventions

OTHER

Standard Medical Care (SMC)

Standard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study.

BEHAVIORAL

Monitoring Contacts

Participants will receive contacts with the research staff at weeks 6, 12, and 18.

BEHAVIORAL

Aerobic Training

Aerobic Training will be supervised exercise. It will occur on 3 days per week and will progress to 50 minutes per session (150 minutes per week). The intensity of the exercise will progress from 60%±5% to 70%±5% of age-predicted maximal heart rate (if taking beta-blocker medication intensity will progress from a Rating of Perceived Exertion of 11-13 to 12-14 based on the 6-20 Borg scale). While walking will be the preferred mode of exercise, alternative forms of cardiovascular exercise (upright cycling, elliptical, etc.) are allowed to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions.

BEHAVIORAL

Resistance Training

Resistance Training will be supervised exercise. It will occur 3 days per week and includes 8 exercises performed in a prespecified order. Week 1-2 sessions focus on familiarization to acclimate the participant to the equipment, proper form, to establish initial weight (load) for training, and with performing multiple sets per day. For Weeks 3-8, participants will engage in 2 sets per exercise with the weight adjusted to elicit muscle fatigue in 8-12 repetitions per set. This progresses to 3 sets per exercise from Week 9 until the end of the intervention period. When 12 repetitions for a specific exercise can be achieved, the resistance will increase for that exercise at the next session. There is a 90 second rest period between each set of an exercise. Heart rate will be monitored throughout these exercise sessions.

OTHER

Nutrition Education

A single counseling session to discuss the dietary recommendations when taking an obesity medication.

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Renee J. Rogers, Ph.D. · University of Kansas Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States

Study Locations