Lifestyle Intervention to Improve Bone Quality
- Conditions
- AgingObesity
- Interventions
- Behavioral: Lifestyle InterventionBehavioral: Healthy Lifestyle Intervention
- Registration Number
- NCT03329963
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.
- Detailed Description
Previous studies had suggested that lifestyle therapy (diet plus exercise) resulting in weight loss in elderly population improves physical function, cardio metabolic risk factors, and cognition/quality of life, but a major complication is loss of BMD. The addition of exercise to diet-induced weight loss attenuated but did not eliminate weight-loss-induced reduction of BMD. Moreover, while long-term maintenance of weight loss and physical function was feasible, sustained lifestyle change led to continued loss of hip BMD, which might predict hip fractures. Although similar BMD loss with weight loss has been observed in younger populations, BMD loss in older adults might be of particular concern because of aggravation of age-related bone loss. Moreover, the belief that obesity protects against fractures has now been challenged by studies demonstrating that obesity is associated with poor bone quality and ankle and leg fractures.Because of previous lack of options to assess bone quality in vivo, there has been little or no scientific study of the possibility that lifestyle therapy in obese older adults improves bone quality. This study represents an unprecedented opportunity to prove the hypothesis that lifestyle therapy intervention improves bone quality and thus, may confer a protective rather than adverse effect on bone health. This will be the first randomized controlled trial (RCT) to comprehensively assess bone quality using novel techniques in response to lifestyle therapy in obese older adults, with major ramifications with regards to defining optimal treatment strategies for this increasingly high-risk older population.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age 65 - 85 years • BMI 30 - 40 kg/m2 • Stable body weight (±2 kg) during the past 6 months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) • Willing to provide informed consent
- Failure to provide informed consent.
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restrictions are contraindicated, or that would interfere with interpretation of results
- Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen ) that would contraindicate exercise or dietary restriction
- Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per week])
- Severe visual or hearing impairments that would interfere with following directions
- Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam score less than 24)
- Uncontrolled hypertension (BP>160/90 mm Hg)
- History of malignancy during the past 5 years (except non-melanoma skin cancers)
- Current use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or bisphosphonates during the last two years)
- Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures - Diabetes mellitus requiring insulin for treatment or with a fasting blood glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary care provider for follow-up and appropriate treatment).
- Terminal illness with life expectancy less than 12 months, as determined by a physician
- Use of any drugs or natural products designed to induce weight loss within past three months.
- Positive exercise stress test for ischemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle intervention Group Lifestyle Intervention Behavioral therapy for weight loss and Exercise Training Healthy lifestyle intervention Group Healthy Lifestyle Intervention Group education sessions that focus on diet exercise and social support.
- Primary Outcome Measures
Name Time Method Change in cortical thickness Change from baseline at 12 months Assessed by using high-resolution peripheral computed tomography (HR-pQCT)
Change in femoral bone strength Change from baseline at 12 months Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)
- Secondary Outcome Measures
Name Time Method Change in circulating cytokines Change from baseline at 12 months Assessed by using enzyme linked immunoassay
Change in areal bone mineral density (BMD) Change from baseline at 12 months Assessed by using dual-energy x-ray absorptiometry
Change in handgrip strength Change from baseline at 12 months Measured by hydraulic hand dynamometer
Change in trabecular number Change from baseline at 12 month Assessed by using HR-pQCT
Change in bone material strength Change from baseline at 12 months Assessed by using microindentation testing
Change in lower extremity strength Change from baseline at 12 months Assessed by using a Biodex dynamometer
Change in gait speed Change from baseline at 12 months as measured by completing the time to walk a certain distance
Change in trabecular thickness Change from baseline at 12 months Assessed by using HR-pQCT
Change in total volumetric BMD Change from baseline at 12 months Assessed by using QCT Pro software
Change in cortical volumetric BMD Change from baseline at 12 months Assessed by using HR-pQCT
Change in general quality of life Change from baseline at 12 months Assessed by using the Short Form-36 questionnaire
Change in mood Change from baseline at 12 months Assessed by using a mood scale questionnaire
Change in composite cognitive z-score Change from baseline at 12 months Using cognitive instrument testing
Change in central volumetric BMD Change from baseline at 12 months Assessed by using CT scan at the spine and hip
Change in fat mass Change from baseline at 12 months Assessed by using dual-energy x-ray absorptiometry
Change in physical performance test Change from baseline at 12 months assessed by using the objective physical performance test
Change in cortical porosity Change from baseline at 12 months Assessed by using HR-pQCT
Change in obesity specific quality of life Change from baseline at 12 months Assessed by using the Impact of weight on quality of life short form (IWQOL-Lite) questionnaire
Change in biochemical marker for bone turnover and bone metabolism Change from baseline at 12 months Assessed by using enzyme linked immunosorbent assay and radioimmunoassay
Change in total body mass Change from baseline at 12 months Assessed byusing dual energy x-ray absorptiometry
Change in trabecular volumetric BMD Change from baseline at 12 months Assessed by using HR-pQCT
Change in stiffness Change from baseline at 12 months Assessed by using HR-pQCT
Change in trabecular separation Change from baseline at 12 months Assessed by using HR-pQCT
Change in micro-finite element analyses strength Change from baseline at 12 months Assessed by using HR-pQCT
Change in cardio metabolic risk factors Change from baseline at 12 months Assessed by measuring metabolic syndrome components
Change in Ray Auditory verbal learning test Change from baseline at 12 months Assessed by using cognitive instrument testing
Change in blood pressure Change from baseline at 12 months Assessed by usingSphygmomanometer
Change in waist circumference Change from baseline at 12 months Assessed by using tape measurement
Change in visceral fat Change from baseline at 12 months Assessed by using dual-energy x-ray absorptiometry
Change in body weight Change from baseline at 12 months Assessed by using weighing scale
Change in wnt signaling pathways Change from baseline at 12 months Assessed by measurements of circulating levels of Wnt 5a and Sfrp5
Change in word list fluency Change from baseline at 12 months Assessed by using cognitive instrument testing
Change in lean mass Change from baseline at 12 months Assessed by using dual-energy x-ray absorptiometry
Change in physical activity using accelerometer Change from baseline at 12 months Assessed by using an accelerometer
Change in sclerostin Change from baseline at 12 months Assessed by using enzyme linked immunoassay
Change in hormones Change from baseline at 12 months Assessed by usingenzyme link immunoassay
Change in thigh mass Change from baseline at 12 months Assessed by using CT scan
Change in adipocytokines Change from baseline at 12 months Assessed by using enzyme linked immunoassay
Change in cortical trabecular BMD Change from baseline at 12 months Assessed by using QCT Pro software
Change in aerobic capacity Change from baseline at 12 months Assessed by using indirect calorimetry during graded treadmill test
Trial Locations
- Locations (1)
Michael E Debakey VA Medical Center
🇺🇸Houston, Texas, United States