Changes in Habitual Physical Activity and Inactivity

Study Overview
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Brief Summary
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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.

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

Conditions
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Habitual Physical Activity, Sedentary Time

Intervention / Treatment
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* Behavioral: exercise training
* Behavioral: sedentary time reduction
* Behavioral: exercsie training plus sedentary time reduction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Group had outcome measures collected and were instructed to not change activity and sedentary time behavior | |
| Experimental: Exercise<br>Participants performed 5 days per week, 40 min per session of exercise training under direct supervision of personal trainer. | Behavioral: exercise training<br>* 12 weeks, 5 days of week, 40 min per session of exercise training<br>|
| Experimental: Sedentary time reduction<br>participants were give strategies to reduce sedentary time | Behavioral: sedentary time reduction<br>* participants provided with strategies to decrease sitting<br>|
| Experimental: exercise plus sedentary time reduction<br>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<br>* 12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in physical activity at 3 weeks | wearable monitor (activPAL) assesses number of steps, MVPA | 3 weeks | 
| change from baseline in physical activity at 6 weeks | wearable monitor (activPAL) assesses number of steps, MVPA | 6 weeks | 
| change from baseline in physical activity at 9 weeks | wearable monitor (activPAL) assesses number of steps, MVPA | 9 weeks | 
| change from baseline in physical activity at 12 weeks | wearable monitor (activPAL) assesses number of steps, MVPA | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical inactivity, exercise training, sedentary time, habitual physical activity