NCT02868710

Brief Summary

The purpose of this study is to: 1) determine the cohort specific technical error to use in the categorization of response rate; 2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO2max and cardiometabolic risk factor responsiveness; 3) Investigate the time course changes throughout 12 weeks of CRF training between an individualized and standardized exercise prescription; and 4) determine if non-responders can become responders if the exercise intensity prescription is modified. It is hypothesized that:

  1. 1.The individualized method will elicit a greater responsiveness for all measurements when compared to the standardized method.
  2. 2.There will be a greater amount of non-responders in the standardized group (based on changes in VO2max).
  3. 3.When participants in the standardized group are considered non-responders and change their exercise prescription to the individualized group, they will become a responder (based on changes in VO2max)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

August 9, 2016

Last Update Submit

October 1, 2018

Conditions

Cardiovascular Disease

Keywords

primary prevention

Outcome Measures

Primary Outcomes (1)

  • Maximal Oxygen Uptake (VO2max)

    12 weeks

Secondary Outcomes (10)

  • Total cholesterol

    12 weeks

  • Low-density lipoprotein

    12 weeks

  • High-density lipoprotein

    12 weeks

  • Triglycerides

    12 weeks

  • Fasting blood glucose

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

Individualized method

EXPERIMENTAL

3 days a week of exercise at the following intensity and energy expenditure: Week 1: HR \> VT1; 5.6 kcal/kg/wk Week 2: HR \> VT1; 8.4 kcal/kg/wk Week 3: HR \> VT1; 11.2 kcal/kg/wk Week 4: HR ≥ VT1 to \<VT2; 11.2 kcal/kg/wk Week 5-6: HR ≥ VT1 to \<VT2; 11.2 kcal/kg/wk Week 7: HR ≥ VT1 to \<VT2; 12.6 kcal/kg/wk Week 8: HR ≥ VT1 to \<VT2; 14 kcal/kg/wk Week 9-10: HR ≥ VT2; 14 kcal/kg/wk Week 11-12: HR ≥ VT2; 15.4 kcal/kg/wk

Other: Exercise

Standardized method

EXPERIMENTAL

3 days a week of exercise at the following intensity and energy expenditure: Week 1: 40-45% HRR; 5.6 kcal/kg/wk Week 2: 40-45% HRR; 8.4 kcal/kg/wk Week 3: 40-45% HRR; 11.2 kcal/kg/wk Week 4: 50-55% HRR; 11.2 kcal/kg/wk Week 5-6: 55-60% HRR; 11.2 kcal/kg/wk Week 7: 55-60% HRR; 12.6 kcal/kg/wk Week 8: 55-60% HRR; 14 kcal/kg/wk Week 9-10: 60-65% HRR; 14 kcal/kg/wk Week 11-12: 60-65% HRR; 15.4 kcal/kg/wk

Other: Exercise

Control

NO INTERVENTION

non-exercise control group Testing at baseline and post-program (12 weeks)

Interventions

ExerciseOTHER

Continuous aerobic exercise prescribed according to two exercise intensity methods: individualized (i.e. ventilatory threshold) and standardized (i.e. heart rate reserve)

Individualized methodStandardized method

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Considered low to moderate risk for cardiovascular disease based on the American College of Sports medicine guidelines
  • Currently sedentary (participating in less than 30 minutes of moderate intensity physical activity on at least three days a week)
  • Resided at an altitude of 2300 meters for at least the last 6 months

You may not qualify if:

  • Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western State Colorado University

Gunnison, Colorado, 82131, United States

Location

Related Publications (1)

  • Weatherwax RM, Harris NK, Kilding AE, Dalleck LC. The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial. Trials. 2016 Dec 19;17(1):601. doi: 10.1186/s13063-016-1735-0.

    PMID: 27993169DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 16, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-10

Locations

US(1)