University of Limerick
Limerick, Munster, V94 T9PX, Ireland
NCT Number: NCT06804629
This protocol details the full methods of a ten-week moderate-to-high intensity, guidelines-based resistance exercise training intervention compared to a low intensity sham attention control among young adult women with analogue Generalized Anxiety Disorder.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Limerick, Munster, V94 T9PX, Ireland
A recent clinical trial supported the anxiolytic effects of regularly-performed resistance exercise training compared to a waitlist control among young adults with and without at least subclinical, or analogue, Generalized Anxiety Disorder. Although the evidence to date is promising, waitlist control conditions cannot control for potential social and psychological benefits of engaging with most interventions, including social contact, expectations for improvement, and mastery experiences, which could potentially be achieved from easier activities. Therefore, this trial aims to replicate the previously investigated World Health Organization and American College of Sports Medicine guidelines-based resistance exercise training program, and expand on this research by more rigorously examining the effects on anxiety and worry symptoms, independent of potential social and psychological benefits of engagement with the intervention. Consequently, this trial quantifies the acute and chronic effects of moderate-to-high intensity, guidelines-based resistance exercise training compared to a low intensity SHAM attention control on signs and symptoms of Generalized Anxiety Disorder among at-risk young adult women with Analogue Generalized Anxiety Disorder. This trial consists of a two-week familiarization protocol, eight weeks of formal resistance exercise training, and a one-month post-intervention follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Resistance exercise training was designed in accordance with World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed such that moderate-to-high intensity participants could achieve two sets of 8-12 repetitions of the eight exercises before volitional fatigue, a deterioration in lifting form, or failure to complete a repetition, using loads of approximately 70-80% of their estimated one-repetition maximum. Completed in the following order, the exercises were: barbell back squat, barbell bench press, hexagon bar deadlift, barbell bent over row, dumbbell lunges, seated dumbbell lateral raises, weighted or unweighted abdominal crunches, and seated dumbbell bicep curls. There was one minute of rest between each set, and two minutes of rest between each exercise. If participants could complete two sets of 12 repetitions, load was increased gradually by approximately 5% in the following session.
Other names: Strength training, Weight-lifting
The low intensity SHAM condition was matched all features of engagement with the moderate-to-high intensity intervention apart from load, and load progression. Low intensity SHAM participants completed the same program with loads of approximately 20% of their estimated one-repetition maximum. To maintain low intensity, repetitions completed on the main, heavier lifts (i.e., back squat, bench press, deadlift, bent over row) were increased from 10 in one session to 12 in the next; load was then increased by approximately 10% in the following session, and 10 reps were performed again. On the remaining lighter, assistance lifts, eight repetitions were performed per set, then one repetition was added to both sets in each session, and load was increased by the smallest increment possible when two sets of 12 repetitions were performed. Borg's 6-20 rating of perceived exertion scores were used to monitor intensity, such that if scores exceeded 11, load and reps were not progressed.
Time frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Time frame: Baseline
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 1
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 4
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 8
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 12
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Baseline
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Pre-week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 2
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 3
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 4
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 5
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 6
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 7
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 8
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 12
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Baseline
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-week 1
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 1
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 2
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 3
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 4
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 5
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 6
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 7
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 8
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 12
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Baseline
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-acute resistance exercise bout week 1
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Post-acute resistance exercise bout week 1
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-acute resistance exercise bout week 8
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Post-acute resistance exercise bout week 8
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Baseline
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Pre-week 1
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 1
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 2
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 3
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 4
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 5
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 6
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 7
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 8
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 12
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Baseline
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Pre-week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 2
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 3
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 4
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 5
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 6
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 7
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 12
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Pre-acute resistance exercise bout week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Post-acute resistance exercise bout week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Pre-acute resistance exercise bout week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Post-acute resistance exercise bout week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Time frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Time frame: Baseline
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 1
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 4
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 8
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 12
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Baseline
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 1
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 4
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 8
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 12
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Baseline
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 1
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 4
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 8
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 12
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Baseline
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Pre-acute resistance exercise bout week 1
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Post-acute resistance exercise bout week 1
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Pre-acute resistance exercise bout week 8
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Post-acute resistance exercise bout week 8
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Week 8
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Baseline
Trail Making Test (Tombaugh, 2004)
Time frame: Pre-acute resistance exercise bout week 1
Trail Making Test (Tombaugh, 2004)
Time frame: Post-acute resistance exercise bout week 1
Trail Making Test (Tombaugh, 2004)
Time frame: Pre-acute resistance exercise bout week 8
Trail Making Test (Tombaugh, 2004)
Time frame: Post-acute resistance exercise bout week 8
Trail Making Test (Tombaugh, 2004)
Time frame: Week 8
Trail Making Test (Tombaugh, 2004)
Time frame: Baseline
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 1
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 4
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 8
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 12
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Pre-acute resistance exercise bout week 1
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Post-acute resistance exercise bout week 1
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Pre-acute resistance exercise bout week 8
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Post-acute resistance exercise bout week 8
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Baseline
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Pre-week 1
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 1
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 2
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 3
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 4
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 5
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 6
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 7
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 8
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 12
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Baseline
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 1
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 4
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 8
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 12
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
University of Limerick
Other
Acute and Chronic Effects of Guidelines-Based Resistance Exercise Training Compared to a Low Intensity SHAM Attention Control Among Young Adult Women With Analogue Generalized Anxiety Disorder: A Protocol for a Randomized Controlled Trial.
Acronym: RETRAIN REP-EX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04116944
Analogue Generalized Anxiety Disorder, Anxiety Disorders
Limerick, Ireland
View Trial Details