Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise Training for the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00953654
First received: August 4, 2009
Last updated: August 3, 2011
Last verified: August 2010
Results First Received: August 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Other: Strength Training
Other: Endurance Training

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women were recruited from from a University and Community setting from August 2009 to March 2010. 1044 women were screened using online screening questionnaires; 853 were excluded for having too few worry symptoms or too high a physical activity level. 55 completed diagnostic interviews - 25 were excluded for no Generalized Anxiety Disorder.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty women met exclusion criteria and were enrolled in the trial.

Reporting Groups
  Description
Resistance Exercise Training Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
Aerobic Exercise Training Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
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.

Participant Flow:   Overall Study
    Resistance Exercise Training     Aerobic Exercise Training     Waiting List Control  
STARTED     10     10     10  
COMPLETED     10     10     10  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Resistance Exercise Training Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
Aerobic Exercise Training Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
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.
Total Total of all reporting groups

Baseline Measures
    Resistance Exercise Training     Aerobic Exercise Training     Waiting List Control     Total  
Number of Participants  
[units: participants]
  10     10     10     30  
Age  
[units: participants]
       
Between 18 and 23 years     6     8     6     20  
Between 24 and 29 years     1     2     1     4  
Between 30 and 37 years     3     0     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  25.6  ± 7.1     20.7  ± 3.0     24.2  ± 6.3     23.5  ± 5.9  
Gender  
[units: participants]
       
Female     10     10     10     30  
Region of Enrollment  
[units: participants]
       
United States     10     10     10     30  
Psychiatric Comorbidity [1]
[units: cases]
       
Specific Phobia     2     5     10     17  
Social Phobia     2     5     5     12  
Obsessive Compulsive Disorder (OCD)     1     1     3     5  
Post-Traumatic Stress Disorder (PTSD)     0     0     2     2  
Major Depressive Disorder (MDD)     1     3     3     7  
Dysthymia     2     0     2     4  
Substance Abuse     1     0     0     1  
Medication [2]
[units: Participants]
       
Contraceptive     5     5     5     15  
Selective Serotonin Reuptake Inhibitor (SSRI)     2     2     3     7  
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)     1     1     0     2  
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)     0     1     1     2  
Muscle Relaxant     1     1     0     2  
Psychostimulant     0     0     1     1  
Antibiotic     0     1     0     1  
Antihistamine     1     0     0     1  
Weight  
[units: Kilograms]
Mean ± Standard Deviation
  60.6  ± 9.1     70.0  ± 15.5     66.4  ± 8.1     65.7  ± 12.2  
Height  
[units: centimeters]
Mean ± Standard Deviation
  162.6  ± 6.2     165.0  ± 7.6     166.5  ± 4.6     164.7  ± 6.6  
[1] Number of comorbid psychiatric diagnoses was assessed using the Adult Version of the Anxiety Disorders Interview Schedule for the DSM-IV (ADIS-IV).
[2] Non-psychoactive and psychoactive medication use was assessed by self-report using a medication use recall questionnaire.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Worry Symptoms   [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One limitation of this trial was the small sample size. Although the research design was sufficiently powered to detect a statistically significant effect for the primary outcome, a larger trial is warranted.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matthew P. Herring, PhD
Organization: The University of Georgia
phone: 706-542-4381
e-mail: mph8@uga.edu


No publications provided


Responsible Party: Matthew P. Herring, The University of Georgia
ClinicalTrials.gov Identifier: NCT00953654     History of Changes
Other Study ID Numbers: UGA-2009-01913-1
Study First Received: August 4, 2009
Results First Received: August 17, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board