Trial Outcomes & Findings for Exercise Training for the Treatment of Generalized Anxiety Disorder (NCT NCT00953654)

Last Updated: 2016-09-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Pre- and post- 6 week training intervention

Results posted on

2016-09-09

Participant Flow

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.

Thirty women met exclusion criteria and were enrolled in the trial.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Training for the Treatment of Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resistance Exercise Training n=10 Participants 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 n=10 Participants 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 n=10 Participants 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 n=30 Participants Total of all reporting groups
Age, Customized ≥18 and ≤23 years	6 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	20 participants n=4 Participants
Age, Customized >23 and ≤29 years	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Age, Customized >29 and ≤37 years	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants
Age, Continuous	25.6 years STANDARD_DEVIATION 7.1 • n=5 Participants	20.7 years STANDARD_DEVIATION 3.0 • n=7 Participants	24.2 years STANDARD_DEVIATION 6.3 • n=5 Participants	23.5 years STANDARD_DEVIATION 5.9 • n=4 Participants
Sex/Gender, Customized Female	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Psychiatric Comorbidity Specific Phobia	2 cases n=5 Participants	5 cases n=7 Participants	10 cases n=5 Participants	17 cases n=4 Participants
Psychiatric Comorbidity Social Phobia	2 cases n=5 Participants	5 cases n=7 Participants	5 cases n=5 Participants	12 cases n=4 Participants
Psychiatric Comorbidity Obsessive Compulsive Disorder (OCD)	1 cases n=5 Participants	1 cases n=7 Participants	3 cases n=5 Participants	5 cases n=4 Participants
Psychiatric Comorbidity Post-Traumatic Stress Disorder (PTSD)	0 cases n=5 Participants	0 cases n=7 Participants	2 cases n=5 Participants	2 cases n=4 Participants
Psychiatric Comorbidity Major Depressive Disorder (MDD)	1 cases n=5 Participants	3 cases n=7 Participants	3 cases n=5 Participants	7 cases n=4 Participants
Psychiatric Comorbidity Dysthymia	2 cases n=5 Participants	0 cases n=7 Participants	2 cases n=5 Participants	4 cases n=4 Participants
Psychiatric Comorbidity Substance Abuse	1 cases n=5 Participants	0 cases n=7 Participants	0 cases n=5 Participants	1 cases n=4 Participants
Medication Contraceptive	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Medication Selective Serotonin Reuptake Inhibitor (SSRI)	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Medication Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Medication Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Medication Muscle Relaxant	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Medication Psychostimulant	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Medication Antibiotic	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Medication Antihistamine	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Weight	60.6 Kilograms STANDARD_DEVIATION 9.1 • n=5 Participants	70.0 Kilograms STANDARD_DEVIATION 15.5 • n=7 Participants	66.4 Kilograms STANDARD_DEVIATION 8.1 • n=5 Participants	65.7 Kilograms STANDARD_DEVIATION 12.2 • n=4 Participants
Height	162.6 centimeters STANDARD_DEVIATION 6.2 • n=5 Participants	165.0 centimeters STANDARD_DEVIATION 7.6 • n=7 Participants	166.5 centimeters STANDARD_DEVIATION 4.6 • n=5 Participants	164.7 centimeters STANDARD_DEVIATION 6.6 • n=4 Participants

PRIMARY outcome

Timeframe: Pre- and post- 6 week training intervention

Outcome measures

Outcome measures
Measure	Resistance Exercise Training n=10 Participants 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 n=10 Participants 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 n=10 Participants 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.
Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings	4 Participants	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6

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.

Outcome measures

Outcome measures
Measure	Resistance Exercise Training n=16 Units on a scale 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 n=16 Units on a scale 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 n=16 Units on a scale 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.
Worry Symptoms Baseline	63.80 Units on a scale (PSWQ) Standard Deviation 9.78	62.1 Units on a scale (PSWQ) Standard Deviation 6.4	64.3 Units on a scale (PSWQ) Standard Deviation 7.01
Worry Symptoms Week 2	59.83 Units on a scale (PSWQ) Standard Deviation 9.93	63.20 Units on a scale (PSWQ) Standard Deviation 4.16	63.4 Units on a scale (PSWQ) Standard Deviation 8.91
Worry Symptoms Week 4	60.3 Units on a scale (PSWQ) Standard Deviation 8.29	58.8 Units on a scale (PSWQ) Standard Deviation 5.2	63.5 Units on a scale (PSWQ) Standard Deviation 7.04
Worry Symptoms Week 6	61.1 Units on a scale (PSWQ) Standard Deviation 10.01	59.3 Units on a scale (PSWQ) Standard Deviation 7.38	65.5 Units on a scale (PSWQ) Standard Deviation 7.62

Adverse Events

Resistance Exercise Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerobic Exercise Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waiting List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew P. Herring, PhD

The University of Georgia

Phone: 706-542-4381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place