Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength Training | Experimental | Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum |
|
| Endurance Training | Experimental | 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. |
|
| Waiting List Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 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. | Pre- and post- 6 week training intervention |
| Worry Symptoms | 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. | Baseline, Week 2, Week 4, Week 6 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew P Herring, MS, MEd | The University of Georgia | Principal Investigator |
| Patrick J O'Connor, PhD | The University of Georgia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Georgia | Athens | Georgia | 30602-6554 | United States |
Thirty women met exclusion criteria and were enrolled in the trial.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Aerobic Exercise Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 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. | Posted | Number | Participants | Pre- and post- 6 week training intervention |
|
Across 6-week intervention
Adverse events including any musculoskeletal injuries or increases in suicidal ideation (measured with ninth item of Beck Depression Inventory-II) were monitored for each patient during each week of the 6-week intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew P. Herring, PhD | The University of Georgia | 706-542-4381 | mph8@uga.edu |
Not provided
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D000076663 | Endurance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Endurance Training | Other | 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. |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Psychiatric Comorbidity | Number of comorbid psychiatric diagnoses was assessed using the Adult Version of the Anxiety Disorders Interview Schedule for the DSM-IV (ADIS-IV). | Number | cases |
|
| Medication | Non-psychoactive and psychoactive medication use was assessed by self-report using a medication use recall questionnaire. | Number | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| Primary | Worry Symptoms | 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. | Posted | Mean | Standard Deviation | Units on a scale (PSWQ) | Baseline, Week 2, Week 4, Week 6 | Units on a scale | Participants |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
|
| Week 4 |
|
| Week 6 |
|