NCT00275145

Brief Summary

This study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for phase_2 cardiovascular-diseases

Timeline
Completed

Started May 2004

Typical duration for phase_2 cardiovascular-diseases

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

Study Start

First participant enrolled

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 24, 2013

Status Verified

November 1, 2011

Enrollment Period

4.6 years

First QC Date

January 10, 2006

Last Update Submit

May 23, 2013

Conditions

Cardiovascular DiseasesHeart DiseasesObesityHyperlipidemiaInsulin ResistanceMetabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

  • Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity

    Month 0, Month 4, Year 1, and Year 1 plus 2 weeks

Secondary Outcomes (1)

  • Metabolic Syndrome (ATP III defined); Maximal Oxygen consumption; muscle biopsy measures (oxidative enzymes, capillary density, myofiber diameter)

    0 mths, 4 mths, 1 year and 1 year and 2 weeks

Study Arms (4)

Resistance Training

EXPERIMENTAL

8 months of Resistance Exercise Training

Behavioral: Resistance Training

Aerobic Exercise

EXPERIMENTAL

8 months of Aerobic Exercise Training

Behavioral: Aerobic Exercise

Combination RT & AT

EXPERIMENTAL

8 months of Combined Aerobic and Resistance Exercise Training

Behavioral: Combo

Control

EXPERIMENTAL

Control/sedentary intervention

Behavioral: Continued Sedentary lifestyle

Interventions

Resistance TrainingBEHAVIORAL

Lifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets

Resistance Training
Aerobic ExerciseBEHAVIORAL

Exercise at 75% of maximal capacity for approximately 2 hours per week

Aerobic Exercise
ComboBEHAVIORAL

Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group

Combination RT & AT
Continued Sedentary lifestyleBEHAVIORAL

No changes

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary (exercises fewer than two times per week)
  • Overweight or mildly obese (body mass index \[BMI\] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women)

You may not qualify if:

  • Diabetes
  • Hypertension
  • Other metabolic or musculoskeletal diseases
  • Current use of or intent to diet
  • Use of confounding medication
  • Overt presence of coronary heart disease
  • Unwilling to be randomized to any group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

  • Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.

    PMID: 38489667DERIVED

  • Collins KA, Fos LB, Ross LM, Slentz CA, Davis PG, Willis LH, Piner LW, Bateman LA, Houmard JA, Kraus WE. Aerobic, Resistance, and Combination Training on Health-Related Quality of Life: The STRRIDE-AT/RT Randomized Trial. Front Sports Act Living. 2021 Feb 11;2:620300. doi: 10.3389/fspor.2020.620300. eCollection 2020.

    PMID: 33644749DERIVED

  • AbouAssi H, Slentz CA, Mikus CR, Tanner CJ, Bateman LA, Willis LH, Shields AT, Piner LW, Penry LE, Kraus EA, Huffman KM, Bales CW, Houmard JA, Kraus WE. The effects of aerobic, resistance, and combination training on insulin sensitivity and secretion in overweight adults from STRRIDE AT/RT: a randomized trial. J Appl Physiol (1985). 2015 Jun 15;118(12):1474-82. doi: 10.1152/japplphysiol.00509.2014.

    PMID: 25882384DERIVED

  • Moker EA, Bateman LA, Kraus WE, Pescatello LS. The relationship between the blood pressure responses to exercise following training and detraining periods. PLoS One. 2014 Sep 10;9(9):e105755. doi: 10.1371/journal.pone.0105755. eCollection 2014.

    PMID: 25208075DERIVED

  • Huffman KM, Koves TR, Hubal MJ, Abouassi H, Beri N, Bateman LA, Stevens RD, Ilkayeva OR, Hoffman EP, Muoio DM, Kraus WE. Metabolite signatures of exercise training in human skeletal muscle relate to mitochondrial remodelling and cardiometabolic fitness. Diabetologia. 2014 Nov;57(11):2282-95. doi: 10.1007/s00125-014-3343-4. Epub 2014 Aug 5.

    PMID: 25091629DERIVED

  • Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.

    PMID: 23019316DERIVED

  • Slentz CA, Bateman LA, Willis LH, Shields AT, Tanner CJ, Piner LW, Hawk VH, Muehlbauer MJ, Samsa GP, Nelson RC, Huffman KM, Bales CW, Houmard JA, Kraus WE. Effects of aerobic vs. resistance training on visceral and liver fat stores, liver enzymes, and insulin resistance by HOMA in overweight adults from STRRIDE AT/RT. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E1033-9. doi: 10.1152/ajpendo.00291.2011. Epub 2011 Aug 16.

    PMID: 21846904DERIVED

  • Bateman LA, Slentz CA, Willis LH, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Comparison of aerobic versus resistance exercise training effects on metabolic syndrome (from the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise - STRRIDE-AT/RT). Am J Cardiol. 2011 Sep 15;108(6):838-44. doi: 10.1016/j.amjcard.2011.04.037. Epub 2011 Jul 7.

    PMID: 21741606DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesObesityHyperlipidemiasInsulin ResistanceMetabolic Syndrome

Interventions

Resistance TrainingExercisecarboxymethylmonobenzocyclooctyne

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • William E. Kraus

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 24, 2013

Record last verified: 2011-11

Locations

US(1)