Lifestyle Intervention to Improve Bone Quality

Obesity Clinical Trial

— LIMB-Q  

Official title:

Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03329963
• Other study ID #: H-40373
• Secondary ID: R01DK109950
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Obesity

Intervention

Behavioral:
• Healthy Lifestyle Intervention
Participants in the this group will receive group educational sessions that focus on diet, exercise, and social support once a month throughout the study. The sessions will provide an opportunity for participants to discuss issues related to living with obesity and aging.Participants will also attend regular scheduled clinic visits for assessment of outcomes.
• Lifestyle Intervention
The lifestyle modification will be achieved by group behavior therapy sessions designed to have older adults acquire positive weight-control skills/attitudes, and practice weight-maintenance skills.Participants will attend weekly group sessions (10-15 persons), which will last ~75-90 minutes. Visit frequency will be decreased to every 2 wks. from 6 to 12 mos. to prevent "treatment fatigue". A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement. The exercise sessions are of ~90 min duration (~15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for one year. Aerobic exercises consist of treadmill, stationary cycling, and stair climbing.

Locations

Country	Name	City	State
United States	Michael E Debakey VA Medical Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Biomedical Research Institute of New Mexico, Michael E. DeBakey VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cortical thickness	Assessed by using high-resolution peripheral computed tomography (HR-pQCT)	Change from baseline at 12 months
Primary	Change in femoral bone strength	Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)	Change from baseline at 12 months
Secondary	Change in bone material strength	Assessed by using microindentation testing	Change from baseline at 12 months
Secondary	Change in lower extremity strength	Assessed by using a Biodex dynamometer	Change from baseline at 12 months
Secondary	Change in physical performance test	assessed by using the objective physical performance test	Change from baseline at 12 months
Secondary	Change in gait speed	as measured by completing the time to walk a certain distance	Change from baseline at 12 months
Secondary	Change in handgrip strength	Measured by hydraulic hand dynamometer	Change from baseline at 12 months
Secondary	Change in trabecular thickness	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in areal bone mineral density (BMD)	Assessed by using dual-energy x-ray absorptiometry	Change from baseline at 12 months
Secondary	Change in trabecular number	Assessed by using HR-pQCT	Change from baseline at 12 month
Secondary	Change in total volumetric BMD	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in cortical volumetric BMD	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in trabecular volumetric BMD	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in stiffness	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in trabecular separation	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in micro-finite element analyses strength	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in cortical porosity	Assessed by using HR-pQCT	Change from baseline at 12 months
Secondary	Change in general quality of life	Assessed by using the Short Form-36 questionnaire	Change from baseline at 12 months
Secondary	Change in obesity specific quality of life	Assessed by using the Impact of weight on quality of life short form (IWQOL-Lite) questionnaire	Change from baseline at 12 months
Secondary	Change in mood	Assessed by using a mood scale questionnaire	Change from baseline at 12 months
Secondary	Change in composite cognitive z-score	Using cognitive instrument testing	Change from baseline at 12 months
Secondary	Change in cardio metabolic risk factors	Assessed by measuring metabolic syndrome components	Change from baseline at 12 months
Secondary	Change in word list fluency	Assessed by using cognitive instrument testing	Change from baseline at 12 months
Secondary	Change in Ray Auditory verbal learning test	Assessed by using cognitive instrument testing	Change from baseline at 12 months
Secondary	Change in blood pressure	Assessed by usingSphygmomanometer	Change from baseline at 12 months
Secondary	Change in biochemical marker for bone turnover and bone metabolism	Assessed by using enzyme linked immunosorbent assay and radioimmunoassay	Change from baseline at 12 months
Secondary	Change in central volumetric BMD	Assessed by using CT scan at the spine and hip	Change from baseline at 12 months
Secondary	Change in waist circumference	Assessed by using tape measurement	Change from baseline at 12 months
Secondary	Change in lean mass	Assessed by using dual-energy x-ray absorptiometry	Change from baseline at 12 months
Secondary	Change in fat mass	Assessed by using dual-energy x-ray absorptiometry	Change from baseline at 12 months
Secondary	Change in visceral fat	Assessed by using dual-energy x-ray absorptiometry	Change from baseline at 12 months
Secondary	Change in physical activity using accelerometer	Assessed by using an accelerometer	Change from baseline at 12 months
Secondary	Change in body weight	Assessed by using weighing scale	Change from baseline at 12 months
Secondary	Change in sclerostin	Assessed by using enzyme linked immunoassay	Change from baseline at 12 months
Secondary	Change in wnt signaling pathways	Assessed by measurements of circulating levels of Wnt 5a and Sfrp5	Change from baseline at 12 months
Secondary	Change in total body mass	Assessed byusing dual energy x-ray absorptiometry	Change from baseline at 12 months
Secondary	Change in hormones	Assessed by usingenzyme link immunoassay	Change from baseline at 12 months
Secondary	Change in thigh mass	Assessed by using CT scan	Change from baseline at 12 months
Secondary	Change in circulating cytokines	Assessed by using enzyme linked immunoassay	Change from baseline at 12 months
Secondary	Change in adipocytokines	Assessed by using enzyme linked immunoassay	Change from baseline at 12 months
Secondary	Change in total volumetric BMD	Assessed by using QCT Pro software	Change from baseline at 12 months
Secondary	Change in cortical trabecular BMD	Assessed by using QCT Pro software	Change from baseline at 12 months
Secondary	Change in aerobic capacity	Assessed by using indirect calorimetry during graded treadmill test	Change from baseline at 12 months