Health Outcomes After Participating in Exercise (HOPE)

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03430115
Collaborator
National Institute on Aging (NIA) (NIH)
588
1
41.2
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    588 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders
    Actual Study Start Date :
    Feb 20, 2018
    Actual Primary Completion Date :
    Jul 27, 2021
    Actual Study Completion Date :
    Jul 27, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Weight loss plus exercise (WL+EX)

    This group was randomized and previously assigned to weight loss plus exercise.

    Exercise alone (EX)

    This group was randomized and previously assigned to exercise alone.

    Weight loss alone (WL)

    This group was randomized and previously assigned to weight loss alone.

    Control

    This group was randomized and previously assigned to control.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    3. Total body lean mass [Baseline]

      Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).

    4. Appendicular lean mass [Baseline]

      Appendicular lean mass will be measured by DXA.

    5. Total body fat mass [Baseline]

      Whole body fat mass will be measured by DXA.

    6. Total hip BMD [Baseline]

      Bone mineral density (BMD) of the total hip will be measured by DXA.

    7. Femoral neck BMD [Baseline]

      Bone mineral density (BMD) of the femoral neck will be measured by DXA.

    8. Lumbar spine BMD [Baseline]

      Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.

    9. Subcutaneous abdominal fat [Baseline]

      Subcutaneous abdominal fat will be measured by computed tomography (CT).

    10. Visceral abdominal fat [Baseline]

      Visceral abdominal fat will be measured by CT.

    11. Thigh inter-muscular adipose tissue [Baseline]

      Thigh inter-muscular adipose tissue will be measured by CT.

    12. Glucose [Baseline]

      Assessed via a standard clinical assay after fasting for at least 8 hours.

    13. Insulin [Baseline]

      Assessed via a standard clinical assay after fasting for at least 8 hours.

    14. Total cholesterol [Baseline]

      Assessed via a standard clinical lipid panel after fasting for at least 8 hours

    15. HDL cholesterol [Baseline]

      Assessed via a standard clinical lipid panel after fasting for at least 8 hours

    16. LDL cholesterol [Baseline]

      Assessed via a standard clinical lipid panel after fasting for at least 8 hours

    17. Triglycerides [Baseline]

      Assessed via a standard clinical lipid panel after fasting for at least 8 hours

    18. 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.

    19. 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.

    20. C-reactive protein [Baseline]

      C-reactive protein (CRP) will be determined using an automated immunoanalyzer.

    21. Interleukin-6 [Baseline]

      Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.

    22. Soluble tumor necrosis factor receptor 1 [Baseline]

      Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Denise Houston, PhD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03430115
    Other Study ID Numbers:
    • IRB00043576
    • 1R01AG056418-01
    First Posted:
    Feb 12, 2018
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021