NCT02351713

Brief Summary

Therefore, the purpose of this study is to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent method (i.e., %HRR). It is hypothesized that:

  1. 1.The ACE three-zone training model will elicit greater mean changes in cardiorespiratory fitness (as measured by VO2max) when compared to the relative percent method.
  2. 2.Participants in the ACE three-zone training model group will be more likely to have favorable VO2max responses; while comparatively, participants in the relative percent method group would be more likely to experience a VO2max nonresponse to exercise training.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 22, 2015

Last Update Submit

January 30, 2015

Conditions

Keywords

primary prevention

Outcome Measures

Primary Outcomes (2)

  • Maximal oxygen uptake (VO2max) as a measure of cardiorespiratory fitness

    12 weeks

  • Estimate of 10-year Cardiovascular Disease Risk

    12 weeks

Study Arms (3)

Threshold based method

EXPERIMENTAL

Exercise Week 1 Heart rate (HR) \< first ventilatory threshold (VT1) 3 days 20 min/day Week 2 HR \< VT1 4 days 25 min/day Week 3 HR \< VT1 4 days 30 min/day Week 4 HR \< VT1 5 days 30 min/day Week 5-6 HR ≥ VT1 to \< second ventilatory threshold (VT2) 5 days 30 min/day Weeks 7-8 HR ≥ VT1 to \< VT2 5 days 30 min/day Weeks 9-12 HR ≥ VT2 5 days 30 min/day

Other: Exercise

Relative percent method

EXPERIMENTAL

Exercise Week 1 40-45% heart rate reserve 3 days 20 min/day Week 2 40-45% heart rate reserve 4 days 25 min/day Week 3 40-45% heart rate reserve 4 days 30 min/day Week 4 40-45% heart rate reserve 5 days 30 min/day Week 5-6 50-55% heart rate reserve 5 days 30 min/day Weeks 7-8 50-55% heart rate reserve 5 days 30min/day Weeks 9-12 60-65% heart rate reserve 5 days 30 min/day

Other: Exercise

Control

NO INTERVENTION

Non-exercise control group

Interventions

Continuous aerobic exercise prescribed according to two exercise intensity methods: threshold based method (i.e., ventilatory threshold) and relative percent method (i.e., heart rate reserve).

Relative percent methodThreshold based method

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wolpern AE, Burgos DJ, Janot JM, Dalleck LC. Is a threshold-based model a superior method to the relative percent concept for establishing individual exercise intensity? a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Jul 4;7:16. doi: 10.1186/s13102-015-0011-z. eCollection 2015.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 30, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-01