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Improving Muscle for Functional Independence Trial

65 Years
79 Years
Open (Enrolling)

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Trial Information

Improving Muscle for Functional Independence Trial

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.


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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)

Outcome Time Frame:

5 month study with baseline and 5 and 18 month follow up assessment visits

Safety Issue:


Principal Investigator

Barbara J Nicklas, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

December 2014

Related Keywords:

  • Obesity
  • Obesity
  • Overweight
  • Older adults
  • resistance training
  • exercise
  • Obesity



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157