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Completed

NCT Number: NCT01580930

Changes in Habitual Physical Activity and Inactivity

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.

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Key information

Conditions

Habitual Physical Activity Behavior Sedentary Behavior Sedentary Time

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Amherst Physical Activity and Health Lab

Amherst, Massachusetts, 01003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Training

Behavioral

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

sedentary time reduction

Behavioral

participants provided with strategies to decrease sitting

exercsie training plus sedentary time reduction

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. change from baseline in physical activity at 3 weeks

    Time frame: 3 weeks

    wearable monitor (activPAL) assesses number of steps, MVPA

  2. change from baseline in physical activity at 6 weeks

    Time frame: 6 weeks

    wearable monitor (activPAL) assesses number of steps, MVPA

  3. change from baseline in physical activity at 9 weeks

    Time frame: 9 weeks

    wearable monitor (activPAL) assesses number of steps, MVPA

  4. change from baseline in physical activity at 12 weeks

    Time frame: 12 weeks

    wearable monitor (activPAL) assesses number of steps, MVPA

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: START

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2012
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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