NCT02632487

Brief Summary

This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable 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

First Submitted

Initial submission to the registry

December 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

December 14, 2015

Last Update Submit

November 20, 2018

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Blood pressure between the groups

    20 weeks

Secondary Outcomes (2)

  • Exercise capacity between the groups

    20 weeks

  • Waist circumference between the groups

    20 weeks

Study Arms (2)

Exercise

ACTIVE COMPARATOR

This group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active.

Behavioral: Exercise

Exercise + Non-Exercise Physical Activity (NEPA)

EXPERIMENTAL

This group will receive 8 weeks of center-based exercise combined with behavioral counseling and a technology intervention designed to increase daily Exercise + Non-Exercise Physical Activity (NEPA).

Behavioral: ExerciseBehavioral: Non-Exercise Physical Activity (NEPA)

Interventions

ExerciseBEHAVIORAL

Center-based walking + balance, stretching, and light resistance

ExerciseExercise + Non-Exercise Physical Activity (NEPA)
Non-Exercise Physical Activity (NEPA)BEHAVIORAL

Behavioral counseling paired with technology intervention to monitor physical activity

Exercise + Non-Exercise Physical Activity (NEPA)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary lifestyle, defined as \<150 min/wk of moderate physical activity by CHAMPS questionnaire
  • Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
  • Willingness to be randomized to either intervention group
  • Willingness to participate in all study procedures

You may not qualify if:

  • Failure to provide informed consent;
  • Regular participation in an exercise training program within the last 3 months
  • Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
  • Office SBP \> 180 mm Hg or DBP \> 110 mm Hg
  • Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
  • Myocardial infarction or stroke within past year
  • Significant cognitive impairment, i.e. known dementia or a Mini-Mental State Examination score \< 24
  • Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS;
  • Severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease
  • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;
  • Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
  • Other significant co-morbid conditions that would impair ability to participate in the intervention
  • Simultaneous participation in another intervention trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Clinical Translational Research Building

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen Anton

    Univesity of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 16, 2015

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

November 20, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

US(1)