Changes in Habitual Physical Activity and Inactivity
START
Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention
2 other identifiers
interventional
57
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 10, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedApril 20, 2012
April 1, 2012
1.2 years
April 10, 2012
April 19, 2012
Conditions
Keywords
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 INTERVENTIONGroup had outcome measures collected and were instructed to not change activity and sedentary time behavior
Exercise
EXPERIMENTALParticipants performed 5 days per week, 40 min per session of exercise training under direct supervision of personal trainer.
Sedentary time reduction
EXPERIMENTALparticipants were give strategies to reduce sedentary time
exercise plus sedentary time reduction
EXPERIMENTALParticipants completed exercise training (5 days per week, 40 min per session) plus were given sedentary time reduction intervention
Interventions
12 weeks, 5 days of week, 40 min per session of exercise training
participants provided with strategies to decrease sitting
12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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