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Health Outcomes After Participating in Exercise (HOPE) (HOPE)

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ClinicalTrials.gov Identifier: NCT03430115
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease
Weight Loss Obesity Aging

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 Type : Observational
Estimated Enrollment : 1150 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 : February 20, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Aerobic fitness [ Time Frame: Baseline ]
    This will be assessed by the 400-meter walk. 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. expanded Short Physical Performance Battery (expSPPB) [ Time Frame: Baseline ]
    The expanded Short Physical Performance Battery (expSPPB) is a modified version of 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. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.

  2. Six minute walk distance test (6MWD) [ Time Frame: Baseline ]
    6MWD, a measure of functional capacity, will assess distance walked in six minutes. The participant is asked to walk at a pace they can maintain for six minutes on a 30 m course and the distance covered recorded.

  3. Knee extension and flexion strength [ Time Frame: Baseline ]
    Maximal isokinetic knee extension and flexion 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 dynamometer will be adjusted for each participant and all adjustments will be recorded to duplicate the position for subsequent assessments. Start and stop angles will be set at 90° and 30°. The best performance of 3 trials will be selected.

  4. Grip strength [ Time Frame: Baseline ]
    Grip strength will be measured twice in each hand using an isometric hydraulic hand dynamometer and the mean value from the stronger hand used.

  5. Body mass index [ Time Frame: Baseline ]
    Body mass index (kg/m2) will be calculated using measured height and weight.

  6. Anthropometric measures [ Time Frame: Baseline ]
    Anthropometric measures of fat distribution will be assessed by circumference measurements of the waist, hip, and thigh using a tape measure.

  7. Body composition and bone mineral density [ Time Frame: Baseline ]
    Fat and whole body and appendicular lean mass will be measured by dual-energy X-ray absorptiometry (DXA). DXA will also be used to analyze bone mineral density (BMD) using specific scans of the anterior-posterior (AP) spine (L1-L4) and proximal femur.

  8. Thigh and body fat distribution [ Time Frame: Baseline ]
    Thigh inter-muscular adipose tissue (IMAT), subcutaneous and visceral abdominal fat (SAT and VAT, respectively), and pericardial fat will be measured by computed tomography (CT).

  9. Volumetric bone mineral density [ Time Frame: Baseline ]
    Helical CT scans of the lumbar spine and hip/pelvis will be used to measure volumetric bone mineral density. The scan coverage for the lumbar spine will be from the top of L1 through the base of L5. The hip/pelvis scan will cover the region from the superior acetabulum to mid-femur. The mid-femur position will be defined as the midpoint between the superior aspect of the greater trochanter and the inferior aspect of the lateral condyle. To locate the mid-point, an anterior-posterior scout of the entire femur will be obtained.

  10. Morphometry [ Time Frame: Baseline ]
    Helical CT scans of the lumbar spine and hip/pelvis will be used to measure. The scan coverage for the lumbar spine will be from the top of L1 through the base of L5. The hip/pelvis scan will cover the region from the superior acetabulum to mid-femur. The mid-femur position will be defined as the midpoint between the superior aspect of the greater trochanter and the inferior aspect of the lateral condyle. To locate the mid-point, an anterior-posterior scout of the entire femur will be obtained.

  11. Bone strength [ Time Frame: Baseline ]
    Helical CT scans of the lumbar spine and hip/pelvis will be used to measure. The scan coverage for the lumbar spine will be from the top of L1 through the base of L5. The hip/pelvis scan will cover the region from the superior acetabulum to mid-femur. The mid-femur position will be defined as the midpoint between the superior aspect of the greater trochanter and the inferior aspect of the lateral condyle. To locate the mid-point, an anterior-posterior scout of the entire femur will be obtained.

  12. Glucose [ Time Frame: Baseline ]
    This test measures the level of glucose in the blood after fasting for at least 8 hours

  13. Liver function [ Time Frame: Baseline ]
    Assessed via a comprehensive metabolic panel

  14. Kidney function [ Time Frame: Baseline ]
    Assessed via a comprehensive metabolic panel

  15. Blood counts [ Time Frame: Baseline ]
    Assessed via a complete blood count

  16. HDL and LDL cholesterol [ Time Frame: Baseline ]
    Assessed via a cholesterol panel

  17. Triglycerides [ Time Frame: Baseline ]
    Assessed via a triglyceride clinical test

  18. Insulin [ Time Frame: Baseline ]
    An estimate of insulin sensitivity by the homeostasis model assessment (HOMA) score will be calculated with the formula: fasting plasma insulin (μU/ml) × glucose (mmol/l)/22.5.

  19. Blood pressure [ Time Frame: 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 and diastolic blood pressure will be defined as the average of three repeated measures.

  20. Inflammatory markers [ Time Frame: Baseline ]
    C-reactive protein (CRP) will be determined using an automated immunoanalyzer. nterleukin-6 (IL-6) and soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine® .



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All participants aged 60 and older at randomization who were randomized to a weight loss intervention that was combined with an exercise intervention (WL+EX, n=458), to an exercise intervention alone (EX alone, n=396), to a weight loss intervention alone (n=176), or to a control group (n=118) from five weight loss and exercise randomized controlled trials.
Criteria

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:

  • Participants with uncontrolled hypertension (≥180/100 mmHg) or resting heart rate <40 or >120 beats per minute
  • Participants who report a recent (past 6 months) cardiac event or procedure or new or recent worsening cardiac symptoms
  • Participants who have had a hip fracture, hip or knee replacement, or spinal surgery within the past 6 months
  • Participants who cannot stand unassisted
  • Participants with bilateral knee replacements
  • Participants who have a history of brain aneurysm, cerebral bleeding in the past 6 months, or blood pressure ≥200/100 mmHg
  • Participants who have had eye surgery (e.g., cataract surgery) within the past month should have testing delayed (temporary exclusion)
  • Surgery on hands or wrists in the past 3 months
  • Pain or arthritis in hands that has gotten worse in the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430115


Contacts
Contact: Denise Houston, PhD 336-713-8217 dhouston@wakehealth.edu
Contact: Kimberly Kennedy 336-713-8567 kkennedy@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Denise Houston, Ph.D.    336-713-8217    dhouston@wakehealth.edu   
Contact: Kimberly Kennedy    336-713-8567    kkennedy@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
Principal Investigator: Denise Houston, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03430115     History of Changes
Other Study ID Numbers: IRB00043576
1R01AG056418-01 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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:
Obese
Exercise

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms