Health Outcomes After Participating in Exercise (HOPE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders

Conditions
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Weight Loss, Obesity, Aging

Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: None - all former participants from the five intervention trials are eligible

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Weight loss plus exercise (WL+EX)<br>This group was randomized and previously assigned to weight loss plus exercise. | |
| Exercise alone (EX)<br>This group was randomized and previously assigned to exercise alone. | |
| Weight loss alone (WL)<br>This group was randomized and previously assigned to weight loss alone. | |
| Control<br>This group was randomized and previously assigned to control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 400 meter walk time | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery score | 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). | Baseline | 
| Knee extension strength | 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. | Baseline | 
| Total body lean mass | Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA). | Baseline | 
| Appendicular lean mass | Appendicular lean mass will be measured by DXA. | Baseline | 
| Total body fat mass | Whole body fat mass will be measured by DXA. | Baseline | 
| Total hip BMD | Bone mineral density (BMD) of the total hip will be measured by DXA. | Baseline | 
| Femoral neck BMD | Bone mineral density (BMD) of the femoral neck will be measured by DXA. | Baseline | 
| Lumbar spine BMD | Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA. | Baseline | 
| Subcutaneous abdominal fat | Subcutaneous abdominal fat will be measured by computed tomography (CT). | Baseline | 
| Visceral abdominal fat | Visceral abdominal fat will be measured by CT. | Baseline | 
| Thigh inter-muscular adipose tissue | Thigh inter-muscular adipose tissue will be measured by CT. | Baseline | 
| Glucose | Assessed via a standard clinical assay after fasting for at least 8 hours. | Baseline | 
| Insulin | Assessed via a standard clinical assay after fasting for at least 8 hours. | Baseline | 
| Total cholesterol | Assessed via a standard clinical lipid panel after fasting for at least 8 hours | Baseline | 
| HDL cholesterol | Assessed via a standard clinical lipid panel after fasting for at least 8 hours | Baseline | 
| LDL cholesterol | Assessed via a standard clinical lipid panel after fasting for at least 8 hours | Baseline | 
| Triglycerides | Assessed via a standard clinical lipid panel after fasting for at least 8 hours | Baseline | 
| Systolic blood pressure | 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. | Baseline | 
| Diastolic blood pressure | 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. | Baseline | 
| C-reactive protein | C-reactive protein (CRP) will be determined using an automated immunoanalyzer. | Baseline | 
| Interleukin-6 | Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®. | Baseline | 
| Soluble tumor necrosis factor receptor 1 | Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Exercise