NCT03734146

Brief Summary

We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a combination of both on blood pressure in overweight or obese middle-aged adults with elevated blood pressure. Participants engaged in supervised exercise sessions 3 times per week for 60 minutes each session. Outcomes were assessed at baseline and after the 8-week intervention. Extra-intervention physical activity and diet were also assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

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

July 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 31, 2018

Last Update Submit

November 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in resting blood pressure

    resting systolic and diastolic blood pressure

    Immediately before and after the 8 week intervention

Study Arms (4)

Aerobic exercise (AE)

EXPERIMENTAL

Engage in supervised aerobic exercise for 60 minutes on 3 days per week for 8 weeks. Exercise is performed on a recumbent bike or treadmill at 50-80% of their heart rate reserve.

Behavioral: Aerobic Exercise

Resistance exercise (RE)

EXPERIMENTAL

Engage in supervised resistance exercise for 60 minutes on 3 days per week for 8 weeks. Exercise consists of 3 sets of 8-12 repetitions of 12 exercises for the major muscle groups.

Behavioral: Resistance Exercise

Combined Resistance and Aerobic Exercise

EXPERIMENTAL

Engage in supervised aerobic resistance exercise for 60 minutes on 3 days per week for 8 weeks. Exercise consists of 30 min aerobic exercise at 50-80% heart rate reserve and 30 min of resistance exercise comprising 2 sets of 8-12 repetitions of 9 exercises for the major muscle groups.

Behavioral: Combined aerobic and resistance exercise

No training control

NO INTERVENTION

No exercise training. Participants will refrain from any moderate-vigorous exercise or resistance training for 8 weeks.

Interventions

180 minutes of moderate-vigorous intensity aerobic exercise per week

Aerobic exercise (AE)

180 minutes of resistance exercise per week

Resistance exercise (RE)

180 minutes of exercise per week with 90 minutes per week coming from moderate-vigorous intensity aerobic exercise and 90 minutes per week coming from resistance exercise

Combined Resistance and Aerobic Exercise

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic/diastolic blood pressure of 120-159/80-99 mm Hg
  • Non-smoking
  • Overweight or obese, with a body mass index of 25-40 kg/m2
  • Inactive--not meeting the aerobic or resistance physical activity guidelines, which means engaging in less than 150 minutes/wk of moderate intensity aerobic exercise and less than 2 days per week of resistance training over the past 3 months.

You may not qualify if:

  • Unstable coronary heart disease or decompensated heart failure
  • Severe pulmonary hypertension or aortic stenosis
  • Acute myocarditis, endocarditis, pericarditis, or aortic dissection
  • Other medical condition that is life-threatening or that can interfere or be aggravated by the exercise training such as cancer, uncontrolled diabetes, severe pain or mobility limitations.
  • Premenopausal women or postmenopausal women taking hormonal replacement therapy
  • Pregnant women or anticipated pregnancy via IVF or other medical procedures during the course of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ExerciseResistance Training

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Duck-chul Lee, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor was blinded to treatment group allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 7, 2018

Study Start

July 15, 2014

Primary Completion

December 19, 2014

Study Completion

December 19, 2014

Last Updated

November 7, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share