Habitual Physical ActivitySTARTNCT01580930
Changes in Habitual Physical Activity and Inactivity
A study testing exercise training, sedentary time reduction and exercsie training plus sedentary time reduction in people with Habitual Physical Activity and Sedentary Time, run by University of Massachusetts, Amherst at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Habitual Physical Activity, Sedentary Time
- What is being tested?
- exercise training, sedentary time reduction and exercsie training plus sedentary time reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Amherst Physical Activity and Health Lab
Amherst, Massachusetts, 01003
About this study
Official title: Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention
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.
- Conditions
- Habitual Physical Activity, Sedentary Time
- Being tested
- exercise training, sedentary time reduction, exercsie training plus sedentary time reduction
- Keywords
- physical inactivity, exercise training, sedentary time, habitual physical activity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
12 weeks, 5 days of week, 40 min per session of exercise training
sedentary time reductionBehavioural
participants provided with strategies to decrease sitting
exercsie training plus sedentary time reductionBehavioural
12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: exercise training |
| Sedentary time reduction | Experimental | participants were give strategies to reduce sedentary time Receives: Behavioral: sedentary time reduction |
| 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 Receives: Behavioral: exercsie training plus sedentary time reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
change from baseline in physical activity at 3 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
Measured: 3 weeks
change from baseline in physical activity at 6 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
Measured: 6 weeks
change from baseline in physical activity at 9 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
Measured: 9 weeks
change from baseline in physical activity at 12 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Habitual Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580930
- Sponsor's protocol ID
- Kozey-Keadle
- Other IDs
- RC1HL099557
- Acronym
- START
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention
- ClinicalTrials.gov ID
- NCT01580930
- Acronym / sponsor ID
- START / Kozey-Keadle
- Conditions
- Habitual Physical Activity, Sedentary Time
- Keywords
- physical inactivity, exercise training, sedentary time, habitual physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Group had outcome measures collected and were instructed to not change activity and sedentary time behavior |
| Exercise | Experimental | Behavioral: exercise trainingParticipants performed 5 days per week, 40 min per session of exercise training under direct supervision of personal trainer. |
| Sedentary time reduction | Experimental | Behavioral: sedentary time reductionparticipants were give strategies to reduce sedentary time |
| exercise plus sedentary time reduction | Experimental | Behavioral: exercsie training plus sedentary time reductionParticipants completed exercise training (5 days per week, 40 min per session) plus were given sedentary time reduction intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training12 weeks, 5 days of week, 40 min per session of exercise training | Behavioural | Exercise |
| sedentary time reductionparticipants provided with strategies to decrease sitting | Behavioural | Sedentary time reduction |
| exercsie training plus sedentary time reduction12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time | Behavioural | exercise plus sedentary time reduction |
Primary outcome
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
4 secondary outcomes
change from baseline in physical activity at 3 weeks
Time frame: 3 weeks
change from baseline in physical activity at 6 weeks
Time frame: 6 weeks
change from baseline in physical activity at 9 weeks
Time frame: 9 weeks
change from baseline in physical activity at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training, sedentary time reduction and exercsie training plus sedentary time reduction in people with Habitual Physical Activity and Sedentary Time, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in sedentary time at 3 weeks (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.