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Improving Muscle for Functional Independence Trial (I'MFIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbara Nicklas, PhD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01049698
First received: January 11, 2010
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
Aging is associated with declines in muscle strength, power, and overall functional ability that lead to disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise, especially resistance exercise, is the only known treatment to consistently improve muscle function and perhaps delay the onset of disability. However, not all individuals experience the same magnitude of benefit from a given exercise stimulus, and accumulating data show that obesity limits muscle adaptations to chronic exercise.Therefore, the proposed study is designed to determine the effects of caloric restriction on improvements in skeletal muscle function in response to RT.

Condition Intervention
Obesity
Behavioral: Resistance Training
Behavioral: Resistance Training + Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Improving Muscle for Functional Independence Trial

Further study details as provided by Barbara Nicklas, PhD, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 126
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Resistance Training
3 d/wk resistance training
Behavioral: Resistance Training
3 d/wk resistance training
Other Names:
  • RT
  • Nautilus resistance machines
Experimental: 2. Resistance Training + Diet
Resistance training plus caloric restriction
Behavioral: Resistance Training + Diet
3 d/w resistance training plus 600 kcal/d deficit
Other Name: RT+CR

Detailed Description:

Design Overview:

This is a 5-month randomized trial in 130 older, overweight or obese, sedentary men and women. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of two 5-month treatments (Phase 3): RT intervention alone (RT) or to an RT with caloric restriction (RT+CR) intervention. Subjects will return for visits the completion of their 5 month intervention. A subset of participants (n=30) will return for an 18 month follow up.

Interventions:

Resistance training+ Caloric Restriction:Participants assigned to RT+CR group will be instructed to follow a hypocaloric diet (-600 kcal/d) for 20 weeks, as well as the resistance training program noted below.In addition, all participants will be provided with a daily calcium (1200 mg/d) and vitamin D (800 IU/d) supplement.The intervention will incorporate meal replacements, nutrition education, and lifestyle behavior modifications.

Resistance training: The maximal weight that can be lifted with correct form in a single repetition (1RM) will be used to prescribe intensity. Strength testing will be repeated every 4 wks and the training loads adjusted so that they are consistent with the 70% 1RM goal. Participants will exercise 3 d/wk on Nautilus resistance machines, under the supervision of two exercise leaders who are trained in basic life support and in emergency management procedures. All exercise will take place at Wake Forest University's Department of Health and Exercise Science Clinical Research Center (CRC). Participants will exercise in small groups which will allow a rotation/rest between machines and enhance the social environment. Heart rate and blood pressure will be measured before and after each session. Subjects will warm-up by walking or cycling for 5 minutes at a slow pace followed by large muscle flexibility exercises. The interventionists will ensure that participants adjust the equipment appropriate to their body size and complete the exercises with correct form. Training sessions will end with a cool-down by walking or cycling for 5 minutes at a slow pace followed by light stretching.

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049698

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Barbara J Nicklas, PhD Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Nicklas, PhD, Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01049698     History of Changes
Other Study ID Numbers: IRB00009098
Study First Received: January 11, 2010
Last Updated: March 10, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.

Keywords provided by Barbara Nicklas, PhD, Wake Forest University Health Sciences:
Obesity
Overweight
Older adults
resistance training
exercise

ClinicalTrials.gov processed this record on May 25, 2017