Clinical trial NCT04116944: The Resistance Exercise Training for Worry Trial
Official title: Effects of Resistance Exercise Among Young Adults With and Without Analogue Generalized Anxiety Disorder: A Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analogue Generalized Anxiety Disorder
Keywords: anxiety
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2019-10-07
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder
Primary purpose: TREATMENT

Brief summary: This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder.

Detailed description: Recent meta-analyses support the chronic anxiolytic effects of resistance exercise training among women with diagnosed Generalized Anxiety Disorder. However, the effects of resistance exercise training among those with subclinical, or analogue-Generalized Anxiety Disorder is unknown. This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder. Analogue-Generalized Anxiety Disorder status was determined using validated cut-scores for both the Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder sub-scale score of 6 or greater, and the Penn State Worry Questionnaire score of 45 or greater. The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were age 18-40y; no medical contraindication to safe participation in resistance exercise training; and no current pregnancy or lactation.

Exclusion Criteria:

-

Primary outcomes:
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: Baseline
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week1
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week 4
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week 8
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: Baseline
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week1
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week 4
measure: Analogue-Generalized Anxiety Disorder Status
timeFrame: week 8
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: Baseline
measure: Anxiety Symptoms
timeFrame: week 1
measure: Anxiety Symptoms
timeFrame: week 2
measure: Anxiety Symptoms
timeFrame: week 3
measure: Anxiety Symptoms
timeFrame: week 4
measure: Anxiety Symptoms
timeFrame: week 5
measure: Anxiety Symptoms
timeFrame: Week 6
measure: Anxiety Symptoms
timeFrame: Week 7
measure: Anxiety Symptoms
timeFrame: Week 8
measure: Depressive Symptoms
timeFrame: Baseline
measure: Depressive Symptoms
timeFrame: Week 1
measure: Depressive Symptoms
timeFrame: Week 2
measure: Depressive Symptoms
timeFrame: Week 3
measure: Depressive Symptoms
timeFrame: Week 4
measure: Depressive Symptoms
timeFrame: Week 5
measure: Depressive Symptoms
timeFrame: Week 6
measure: Depressive Symptoms
timeFrame: Week 7
measure: Depressive Symptoms
timeFrame: Week 8
measure: Mood
timeFrame: Baseline
measure: Mood
timeFrame: Week 1
measure: Mood
timeFrame: Week 2
measure: Mood
timeFrame: Week 3
measure: Mood
timeFrame: Week 4
measure: Mood
timeFrame: Week 5
measure: Mood
timeFrame: Week 6
measure: Mood
timeFrame: Week 7
measure: Mood
timeFrame: Week 8
measure: Irritability
timeFrame: Baseline
measure: Irritability
timeFrame: Week 1
measure: Irritability
timeFrame: Week 2
measure: Irritability
timeFrame: Week 3
measure: Irritability
timeFrame: Week 4
measure: Irritability
timeFrame: Week 5
measure: Irritability
timeFrame: Week 6
measure: Irritability
timeFrame: Week 7
measure: Irritability
timeFrame: Week 8
measure: Sleep Quality
timeFrame: Baseline
measure: Sleep Quality
timeFrame: Week 1
measure: Sleep Quality
timeFrame: Week 2
measure: Sleep Quality
timeFrame: Week 3
measure: Sleep Quality
timeFrame: Week 4
measure: Sleep Quality
timeFrame: Week 5
measure: Sleep Quality
timeFrame: Week 6
measure: Sleep Quality
timeFrame: Week 7
measure: Sleep Quality
timeFrame: Week 8
measure: Non-Intervention Physical Activity
timeFrame: Baseline
measure: Non-Intervention Physical Activity
timeFrame: Week 1
measure: Non-Intervention Physical Activity
timeFrame: Week 2
measure: Non-Intervention Physical Activity
timeFrame: Week 3
measure: Non-Intervention Physical Activity
timeFrame: Week 4
measure: Non-Intervention Physical Activity
timeFrame: Week 5
measure: Non-Intervention Physical Activity
timeFrame: Week 6
measure: Non-Intervention Physical Activity
timeFrame: Week 7
measure: Non-Intervention Physical Activity
timeFrame: Week 8
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Baseline
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 1
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 2
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 3
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 4
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 5
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 6
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 7
measure: A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
timeFrame: Week 8
measure: Attentional Biases
timeFrame: Baseline
measure: Attentional Biases
timeFrame: Week 1
measure: Attentional Biases
timeFrame: Week 8
measure: Cognitive Function
timeFrame: Baseline
measure: Cognitive Function
timeFrame: Week1
measure: Cognitive Function
timeFrame: Week 8
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: The Department of Physical Education and Sport Sciences Building
Study officials:
References:
citation: Gordon BR, McDowell CP, Lyons M, Herring MP. The effects of acute resistance exercise among young adults: A randomized controlled trial. J Affect Disord. 2022 Feb 15;299:102-107. doi: 10.1016/j.jad.2021.11.049. Epub 2021 Nov 18.
citation: Gordon BR, McDowell CP, Lyons M, Herring MP. Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Sci Rep. 2020 Oct 16;10(1):17548. doi: 10.1038/s41598-020-74608-6.