Health Outcomes After Participating in Exercise (HOPE)

Completed

• Conditions: Obesity; Aging; Weight Loss

• Registration Number: NCT03430115
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. Obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. The overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

Detailed Description

Obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. Although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. Because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. The goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

Study Timeline

• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Study Start: 2018-02-20
• Primary Completion: 2021-07-27
• Study Completion: 2021-07-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

• All former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview.

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Exclusion Criteria

• None - all former participants from the five intervention trials are eligible

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
400 meter walk time	Baseline	Participants are instructed to complete the 400 m distance (on a flat indoor surface) as quickly as possible at a maintainable pace and the time to complete the walk is recorded in seconds.

Secondary Outcome Measures

Name	Time	Method
Knee extension strength	Baseline	Maximal isokinetic knee extension strength. Maximal isokinetic knee extension strength will be measured using an isokinetic dynamometer (Biodex) at 60°/sec with the participant sitting and the hips and knee flexed at 90°. The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used.
Total body fat mass	Baseline	Whole body fat mass will be measured by DXA.
Subcutaneous abdominal fat	Baseline	Subcutaneous abdominal fat will be measured by computed tomography (CT).
Appendicular lean mass	Baseline	Appendicular lean mass will be measured by DXA.
Interleukin-6	Baseline	Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.
Glucose	Baseline	Assessed via a standard clinical assay after fasting for at least 8 hours.
Insulin	Baseline	Assessed via a standard clinical assay after fasting for at least 8 hours.
LDL cholesterol	Baseline	Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Short Physical Performance Battery score	Baseline	The Short Physical Performance Battery (SPPB) is a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. Each of the three performance measures is assigned a score ranging from 0 (inability to do the test) to 4 (the highest level of performance) and summed to create an SPPB summary score ranging from 0 (worst) to 12 (best).
Total body lean mass	Baseline	Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).
Femoral neck BMD	Baseline	Bone mineral density (BMD) of the femoral neck will be measured by DXA.
Lumbar spine BMD	Baseline	Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.
Visceral abdominal fat	Baseline	Visceral abdominal fat will be measured by CT.
Diastolic blood pressure	Baseline	Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Diastolic blood pressure will be defined as the average of three repeated measures.
Soluble tumor necrosis factor receptor 1	Baseline	Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.
Total hip BMD	Baseline	Bone mineral density (BMD) of the total hip will be measured by DXA.
Thigh inter-muscular adipose tissue	Baseline	Thigh inter-muscular adipose tissue will be measured by CT.
Total cholesterol	Baseline	Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Systolic blood pressure	Baseline	Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Systolic blood pressure will be defined as the average of three repeated measures.
HDL cholesterol	Baseline	Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Triglycerides	Baseline	Assessed via a standard clinical lipid panel after fasting for at least 8 hours
C-reactive protein	Baseline	C-reactive protein (CRP) will be determined using an automated immunoanalyzer.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States