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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01049698 |
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Date of registration:
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11/01/2010 |
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Primary sponsor: |
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Public title:
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Improving Muscle for Functional Independence Trial
I'MFIT |
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Scientific title:
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Improving Muscle for Functional Independence Trial |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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130 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01049698 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Barbara Nicklas, PhD |
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Address:
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Telephone:
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336-713-8548 |
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Email:
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bnicklas@wfubmc.edu |
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Affiliation:
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Name:
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Barbara J Nicklas, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wake Forest University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BMI=27-34.9 kg/m2
- No resistance training for past 6 mos
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or resistance exercise
including severe arthritis or musculoskeletal disorders, knee or hip replacement or
spinal surgery in past year
- No broken bones in the past 6 months
- Able to provide own transportation to study visits and intervention
- Not involved in any other research study and not undergoing physical therapy
- Not dependent on a cane or walker
Exclusion Criteria:
- Weight loss or gain (±5%) in past 6 months
- Body mass >136 kg (DXA limit)
- Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
- Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
- Uncontrolled hypertension (BP>180/100 mmHg)
- Abnormal kidney function or liver blood tests
- Past or current cardiovascular disease, including uncontrolled angina or
dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke,
history of myocardial infarction, use of defibrillator or major heart surgery, or
deep vein thrombosis or pulmonary embolus
- Past or current respiratory disease (requiring steroid treatment or supplemental
oxygen)
- Past or current clinical diagnoses of neurological or hematological disease
- Use of any medications that could influence study variables (growth/steroid hormones,
prescription anti-inflammatory medications, or beta blockers, Coumadin or any other
blood thinner, including Plavix, Ticid, and Aggrenox)
- Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
- Clinically evident edema or anemia
Age minimum:
65 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Resistance Training
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Behavioral: Resistance Training + Diet
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Primary Outcome(s)
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Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)
[Time Frame: 5 month study with baseline and 5 and 18 month follow up assessment visits]
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Secondary Outcome(s)
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single-fiber contractile force and power, intramyocellular lipid (IMCL), muscle gene and protein expression of interleukin-6 (IL-6) and tumor necrosis factor alpha.
[Time Frame: baseline and 5 and 18-month follow-up]
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Secondary ID(s)
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IRB00009098
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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