- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953654
Exercise Training for the Treatment of Generalized Anxiety Disorder
July 29, 2016 updated by: University of Georgia
Exercise Training for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial Comparing Endurance and Strength Training Among Sedentary Women With Generalized Anxiety Disorder.
The purpose of this study is to compare the effects of 6 weeks of endurance or strength training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder (GAD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Athens, Georgia, United States, 30602-6554
- The University of Georgia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 18-39 years
- Principal diagnosis of Generalized Anxiety Disorder according to DSM-IV diagnostic criteria (comorbidities will be acceptable as long as Generalized Anxiety Disorder is the principal diagnosis)
Exclusion Criteria:
- A score of less than 45 on the Penn State Worry Questionnaire
- A score of less than 7 on the Generalized Anxiety Disorder section of the Psychiatric Diagnostic Screening Questionnaire
- Expending greater than 250 kilocalories per kilogram body weight per week as measured by a 7-day physical activity recall questionnaire
- Engaging in greater than 6 exercise bouts in the month prior to recruitment
- Pregnancy
- Any medical contraindications (cardiovascular or musculoskeletal) to exercise training according to American College of Sports Medicine guidelines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Strength Training
Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
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6 weeks of strength training exercise sessions involving leg press, leg curl, and leg extension exercises twice weekly at an intensity progressing from 50% to 75% of predicted one-repetition maximum across the 6 weeks of the trial.
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EXPERIMENTAL: Endurance Training
Six-week lower-body dynamic cycling exercise condition completed twice weekly and matched to the strength training arm on total work completed, total time actively engaged in exercise and load progression.
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Six weeks of lower-body dynamic cycling exercise completed on an electronically-braked cycle ergometer twice weekly.
The intervention will be matched to the strength training intervention on total work completed, total time actively engaged in exercise, a focus on leg muscles, and load (intensity) progression across the 6 week training protocol.
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NO_INTERVENTION: Waiting List Control
Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings
Time Frame: Pre- and post- 6 week training intervention
|
GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty.
Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment.
Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.
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Pre- and post- 6 week training intervention
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Worry Symptoms
Time Frame: Baseline, Week 2, Week 4, Week 6
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Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ).
The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms.
Participants rate items from 1 "not at all typical of me" to 5 "very typical of me."
Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms.
Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6.
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Baseline, Week 2, Week 4, Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew P Herring, MS, MEd, The University of Georgia
- Study Director: Patrick J O'Connor, PhD, The University of Georgia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (ACTUAL)
May 1, 2010
Study Completion (ACTUAL)
May 1, 2010
Study Registration Dates
First Submitted
August 4, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (ESTIMATE)
August 6, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 9, 2016
Last Update Submitted That Met QC Criteria
July 29, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGA-2009-01913-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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