Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly (FIT)

The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.

Study Overview

• Status: Completed
• Conditions: Elderly; Sedentary
• Intervention / Treatment: Other: Regional Specific Training Stimulus (RSTS); Other: Aerobic Exercise Regimen (AE)

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Center for Living; Wallace Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >70 yrs of age
• Sedentary (exercising <1 day/wk)
• Non-smokers
• Able to ambulate without use of an assistive device
• Able to walk between 200-450m on a 6-minute walk test

Exclusion Criteria:

• Oxygen dependent
• Recent medications changes (within 3 months)
• Current Smokers
• Fixed-rate pacemakers
• Uncontrolled hypertension or Type II diabetes
• Positive ECG changes or angina during CPX testing
• Unable to complete a maximal CPX to volitional fatigue
• AHA Class D, or NYHA Class III or IV heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Regional Specific Training (RSTS); The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.	Other: Regional Specific Training Stimulus (RSTS); The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
EXPERIMENTAL: Aerobic Exercise (AE); Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.	Other: Aerobic Exercise Regimen (AE); Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Exercise Capacity	Exercise capacity was assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption and peak walking time.	Baseline, 4 weeks, and 12 weeks
Change in Maximal Strength	Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.	Baseline, 4 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Ability	The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).	Baseline, 4 weeks and 12 Weeks
Change In Vascular Function	Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), and arterial stiffness (pulse wave velocity and pulse wave reflection).	Baseline, 4 weeks, and 12 weeks
Change in Skeletal Muscle Physiology	Capillary density (mm2) and capillary to fiber ratio will be evaluated. Fiber type will be also determined to identify for types I, IIa and IIb muscle fibers.	Baseline, 4 weeks, and 12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)

Publications and helpful links

General Publications

• Woessner MN, Welsch MA, VanBruggen MD, Johannsen NM, Credeur DP, Pieper CF, Sloane R, Earnest CP, Ortiz De Zevallos Munoz J, Church TS, Ravussin E, Kraus WE, Allen JD. Impact of a Novel Training Approach on Hemodynamic and Vascular Profiles in Older Adults. J Aging Phys Act. 2022 Apr 1;30(2):196-203. doi: 10.1123/japa.2020-0509. Epub 2021 Aug 4.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (ESTIMATE): July 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 4, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Aging; Vascular; Functional Capacity; Exercise Independence; Peripheral Adaptations
• Other Study ID Numbers: Pro00019806; 1RC1AG035822-01 (NIH)