NCT01580930

Brief Summary

The purpose of this study is to determine if individuals involved in exercise training change habitual activity and inactivity behavior outside of exercise training. Eligible participants were randomly assigned to one of four groups: control, exercise training, sedentary time reduction, or exercise training plus sedentary time reduction. It was hypothesized that participants in the exercise training group will compensate for exercise training by reducing free-living physical activity behavior and increasing sedentary time. Participant free-living behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL wearable monitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

April 10, 2012

Last Update Submit

April 19, 2012

Conditions

Keywords

physical inactivityexercise trainingsedentary timehabitual physical activity

Outcome Measures

Primary Outcomes (4)

  • change from baseline in sedentary time at 3 weeks

    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

    3 weeks

  • change from baseline in sedentary time at 6 weeks

    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

    6 weeks

  • change from baseline in sedentary time at 9 weeks

    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

    9 weeks

  • change from baseline in sedentary time at 12 weeks

    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

    12 weeks

Secondary Outcomes (4)

  • change from baseline in physical activity at 3 weeks

    3 weeks

  • change from baseline in physical activity at 6 weeks

    6 weeks

  • change from baseline in physical activity at 9 weeks

    9 weeks

  • change from baseline in physical activity at 12 weeks

    12 weeks

Study Arms (4)

Control group

NO INTERVENTION

Group had outcome measures collected and were instructed to not change activity and sedentary time behavior

Exercise

EXPERIMENTAL

Participants performed 5 days per week, 40 min per session of exercise training under direct supervision of personal trainer.

Behavioral: exercise training

Sedentary time reduction

EXPERIMENTAL

participants were give strategies to reduce sedentary time

Behavioral: sedentary time reduction

exercise plus sedentary time reduction

EXPERIMENTAL

Participants completed exercise training (5 days per week, 40 min per session) plus were given sedentary time reduction intervention

Behavioral: exercsie training plus sedentary time reduction

Interventions

12 weeks, 5 days of week, 40 min per session of exercise training

Exercise

participants provided with strategies to decrease sitting

Sedentary time reduction

12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time

exercise plus sedentary time reduction

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible participants were those at increased risk of cardiovascular disease, based on meeting two of the following three criteria:
  • Pre-hypertensive: resting blood pressure between 125-160 mm Hg systolic and/or 85-100 mm Hg diastolic,
  • overweight/obese: body mass index (BMI) between 25 and 45 kg∙m-2,
  • high central adiposity: as defined by elevated natural waist circumference (\> 102 cm \[males\] \> 88cm \[females\]), a surrogate measure of visceral fat
  • low aerobic fitness (VO2 peak ≤ 50th percentile of age and sex specific norms)
  • exercising less than three days per week for less than 20 minutes per session for the preceding six months

You may not qualify if:

  • major orthopedic limitations,
  • wheelchair use or musculoskeletal problems that affected mobility,
  • life-threatening illness (e.g., terminal cancer),
  • chronic diseases (e.g., diagnosed heart disease, diabetes, emphysema) or
  • any condition for which a physician did not recommend exercise. Participants were excluded if they had gastric bypass or lap-band surgery within the last year, were taking medication for type II diabetes (e.g. metformin) or beta-blocker medication for high blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Amherst Physical Activity and Health Lab

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 19, 2012

Study Start

March 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations