Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

NCT ID: NCT01899586

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-11-30

Brief Summary

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.

Conditions

Elderly; Sedentary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Regional Specific Training Stimulus (RSTS)

Intervention Type: OTHER

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.

Aerobic Exercise (AE)

Whole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.

Group Type: EXPERIMENTAL

Aerobic Exercise Regimen (AE)

Intervention Type: OTHER

Whole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.

Interventions

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.

Intervention Type: OTHER

Aerobic Exercise Regimen (AE)

Whole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason D Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Pennington Biomedical Center

Baton Rouge, Louisiana, United States

Duke Center for Living; Wallace Clinic

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34348230 (View on PubMed)

Other Identifiers

1RC1AG035822-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00019806

Identifier Type: -

Identifier Source: org_study_id