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Clinical Trials/NCT01580930
NCT01580930CompletedNot Applicable

Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention

University of Massachusetts, Amherst1 site in 1 country57 target enrollmentStarted: March 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
1
Primary Endpoint
change from baseline in sedentary time at 3 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: exercise training (Behavioral)

Sedentary time reduction

Experimental

participants were give strategies to reduce sedentary time

Intervention: sedentary time reduction (Behavioral)

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

Intervention: exercsie training plus sedentary time reduction (Behavioral)

Outcomes

Primary Outcomes

change from baseline in sedentary time at 3 weeks

Time Frame: 3 weeks

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

change from baseline in sedentary time at 6 weeks

Time Frame: 6 weeks

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

change from baseline in sedentary time at 9 weeks

Time Frame: 9 weeks

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

change from baseline in sedentary time at 12 weeks

Time Frame: 12 weeks

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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