Changes in Habitual Physical Activity and Inactivity

Sedentary Time Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580930
• Other study ID #: Kozey-Keadle
• Secondary ID: RC1HL099557
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: April 19, 2012
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

Eligible participants were those at increased risk of cardiovascular disease, based on meeting two of the following three criteria:

1. Pre-hypertensive: resting blood pressure between 125-160 mm Hg systolic and/or 85-100 mm Hg diastolic,

2. overweight/obese: body mass index (BMI) between 25 and 45 kg·m-2,

3. high central adiposity: as defined by elevated natural waist circumference (> 102 cm [males] > 88cm [females]), a surrogate measure of visceral fat

4. low aerobic fitness (VO2 peak = 50th percentile of age and sex specific norms)

5. 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Habitual Physical Activity
• Sedentary Time

Intervention

Behavioral:
• exercise training
12 weeks, 5 days of week, 40 min per session of exercise training
• sedentary time reduction
participants provided with strategies to decrease sitting
• exercsie training plus sedentary time reduction
12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time

Locations

Country	Name	City	State
United States	UMass Amherst Physical Activity and Health Lab	Amherst	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	change from baseline in physical activity at 3 weeks	wearable monitor (activPAL) assesses number of steps, MVPA	3 weeks	No
Secondary	change from baseline in physical activity at 6 weeks	wearable monitor (activPAL) assesses number of steps, MVPA	6 weeks	No
Secondary	change from baseline in physical activity at 9 weeks	wearable monitor (activPAL) assesses number of steps, MVPA	9 weeks	No
Secondary	change from baseline in physical activity at 12 weeks	wearable monitor (activPAL) assesses number of steps, MVPA	12 weeks	No