The Resistance Exercise Training for Worry Trial

Effects of Resistance Exercise Among Young Adults With and Without Analogue Generalized Anxiety Disorder: A Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Analogue Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Resistance exercise training; Other: Wait-list

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • The Department of Physical Education and Sport Sciences Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Analogue-Generalized Anxiety Disorder Resistance Training; Resistance exercise training among young adults with analogue-Generalized Anxiety Disorder	Behavioral: Resistance exercise training; The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed to be performed at a moderate intensity. The resistance of each exercise was such that when participants could successfully complete 2 sets of 12 repetitions at a certain load, the resistance was increased incrementally up to 5% for the following session. Exercise sessions were scheduled with at least one day of rest between sessions. The eight exercises included the barbell squat, barbell bench press, hexagon bar deadlift, dumbbell shoulder lateral raise, barbell bent over rows, dumbbell lunges, dumbbell curls, and abdominal crunches.; Other Names: strength training; weight-lifting
Other: Analogue-Generalized Anxiety Disorder Wait-List; 8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder	Other: Wait-list; Participants randomized to the delayed-start wait-list condition completed questionnaires once-weekly. The investigator sent a weekly email to the participant providing links to the questionnaires. Participants that completed the eight-week wait-list condition were offered the eight weeks of RET either immediately upon completion, or later at a time of their convenience while the trial was ongoing. Each participant randomized to the eight-week wait-list also completed two 30-minute bouts of seated quiet rest in an empty room at weeks one and eight.
Experimental: Non-Analogue-Generalized Anxiety Disorder Resistance Training; Resistance exercise training among young adults without analogue-Generalized Anxiety Disorder	Behavioral: Resistance exercise training; The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed to be performed at a moderate intensity. The resistance of each exercise was such that when participants could successfully complete 2 sets of 12 repetitions at a certain load, the resistance was increased incrementally up to 5% for the following session. Exercise sessions were scheduled with at least one day of rest between sessions. The eight exercises included the barbell squat, barbell bench press, hexagon bar deadlift, dumbbell shoulder lateral raise, barbell bent over rows, dumbbell lunges, dumbbell curls, and abdominal crunches.; Other Names: strength training; weight-lifting
Other: Non-Analogue-Generalized Anxiety Disorder Wait-List; 8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder	Other: Wait-list; Participants randomized to the delayed-start wait-list condition completed questionnaires once-weekly. The investigator sent a weekly email to the participant providing links to the questionnaires. Participants that completed the eight-week wait-list condition were offered the eight weeks of RET either immediately upon completion, or later at a time of their convenience while the trial was ongoing. Each participant randomized to the eight-week wait-list also completed two 30-minute bouts of seated quiet rest in an empty room at weeks one and eight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analogue-Generalized Anxiety Disorder Status	The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)	Baseline
Analogue-Generalized Anxiety Disorder Status	The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)	week1
Analogue-Generalized Anxiety Disorder Status	The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)	week 4
Analogue-Generalized Anxiety Disorder Status	The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)	week 8
Analogue-Generalized Anxiety Disorder Status	The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)	Baseline
Analogue-Generalized Anxiety Disorder Status	The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)	week1
Analogue-Generalized Anxiety Disorder Status	The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)	week 4
Analogue-Generalized Anxiety Disorder Status	The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	Baseline
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	week 1
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	week 2
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	week 3
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	week 4
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	week 5
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	Week 6
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	Week 7
Anxiety Symptoms	State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)	Week 8
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Baseline
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 1
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 2
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 3
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 4
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 5
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 6
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 7
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)	Week 8
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Baseline
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 1
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 2
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 3
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 4
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 5
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 6
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 7
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 8
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Baseline
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 1
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 2
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 3
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 4
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 5
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 6
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 7
Irritability	21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)	Week 8
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Baseline
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 1
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 2
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 3
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 4
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 5
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 6
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 7
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)	Week 8
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Baseline
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 1
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 2
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 3
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 4
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 5
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 6
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 7
Non-Intervention Physical Activity	7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)	Week 8
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Baseline
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 1
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 2
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 3
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 4
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 5
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 6
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 7
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)	Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health	Week 8
Attentional Biases	Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)	Baseline
Attentional Biases	Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)	Week 1
Attentional Biases	Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)	Week 8
Cognitive Function	Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)	Baseline
Cognitive Function	Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)	Week1
Cognitive Function	Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)	Week 8

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: Irish Research Council

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): May 3, 2019

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2017_03_18_EHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcomes measures will be made available.
• IPD Sharing Time Frame: Primary outcome data will be made available for five years at six months following publication of primary outcome summary data. Secondary outcome data will be made available for five years at six months following publications of secondary outcome summary data.
• IPD Sharing Access Criteria: Proposals should be directed to matthew.herring@ul.ie. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No