Improving Muscle for Functional Independence Trial
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)
5 month study with baseline and 5 and 18 month follow up assessment visits
Barbara J Nicklas, PhD
Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|