The Resistance Exercise Training for Worry Trial: Replication and Expansion (RETRAIN REP-EX)

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.

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.

Study Overview

• Status: Completed
• Conditions: Analogue Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Moderate-to-High Intensity Resistance Exercise Training; Behavioral: Low Intensity SHAM Resistance Exercise Training Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Munster
    • Limerick, Munster, Ireland, V94 T9PX
      • University of Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female
• Aged 18-40y
• Met criteria for analogue Generalized Anxiety Disorder

Exclusion Criteria:

• Medical contraindications to doing resistance exercise training
• Currently involved in formal resistance exercise training
• Currently pregnant or post-partum

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate-to-High Intensity Resistance Exercise Training; Moderate-to-high intensity, guidelines-based resistance exercise training completed at 70-80% of the estimated one-repetition maximum	Behavioral: Moderate-to-High Intensity Resistance Exercise Training; 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
Sham Comparator: Low Intensity SHAM Resistance Exercise Training Attention Control; Low intensity SHAM Resistance Exercise Training completed at 20% of the estimated one-repetition maximum	Behavioral: Low Intensity SHAM Resistance Exercise Training Attention Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analogue Generalized Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)	Baseline
Analogue Generalized Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)	Week 1
Analogue Generalized Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)	Week 4
Analogue Generalized Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)	Week 8
Analogue Generalized Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)	Week 12
Analogue Generalized Anxiety Disorder Status	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)	Baseline
Analogue Generalized Anxiety Disorder Status	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)	Week 1
Analogue Generalized Anxiety Disorder Status	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)	Week 4
Analogue Generalized Anxiety Disorder Status	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)	Week 8
Analogue Generalized Anxiety Disorder Status	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)	Week 12
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Baseline
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Pre-week 1
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 1
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 2
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 3
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 4
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 5
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 6
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 7
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 8
Worry Symptoms	16-item Penn State Worry Questionnaire (Meyer et al., 1990)	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Baseline
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Pre-week 1
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 1
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 2
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 3
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 4
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 5
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 6
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 7
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 8
Anxiety Symptoms	Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Week 12
Anxiety Symptoms	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Baseline
Anxiety Symptoms	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Pre-acute resistance exercise bout week 1
Anxiety Symptoms	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Post-acute resistance exercise bout week 1
Anxiety Symptoms	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Pre-acute resistance exercise bout week 8
Anxiety Symptoms	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)	Post-acute resistance exercise bout week 8
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Baseline
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Pre-week 1
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 1
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 2
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 3
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 4
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 5
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 6
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 7
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 8
Depressive Symptoms	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)	Week 12
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Pre-week 1
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Week 12
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Pre-acute resistance exercise bout week 1
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Post-acute resistance exercise bout week 1
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Pre-acute resistance exercise bout week 8
Mood	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)	Post-acute resistance exercise bout week 8
Analogue Major Depressive Disorder Status	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)	Baseline
Analogue Major Depressive Disorder Status	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)	Week 1
Analogue Major Depressive Disorder Status	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)	Week 4
Analogue Major Depressive Disorder Status	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)	Week 8
Analogue Major Depressive Disorder Status	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)	Week 12
Analogue Panic Disorder Status	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Baseline
Analogue Panic Disorder Status	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 1
Analogue Panic Disorder Status	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 4
Analogue Panic Disorder Status	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 8
Analogue Panic Disorder Status	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 12
Analogue Social Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Baseline
Analogue Social Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 1
Analogue Social Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 4
Analogue Social Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 8
Analogue Social Anxiety Disorder Status	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)	Week 12
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Baseline
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Week 1
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Week 4
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Week 8
Sleep Quality	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Week 12
Irritability Symptoms	21-item Irritability Questionnaire (Craig et al., 2008)	Baseline
Irritability Symptoms	21-item Irritability Questionnaire (Craig et al., 2008)	Week 1
Irritability Symptoms	21-item Irritability Questionnaire (Craig et al., 2008)	Week 4
Irritability Symptoms	21-item Irritability Questionnaire (Craig et al., 2008)	Week 8
Irritability Symptoms	21-item Irritability Questionnaire (Craig et al., 2008)	Week 12
Rumination	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)	Baseline
Rumination	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)	Week 1
Rumination	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)	Week 4
Rumination	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)	Week 8
Rumination	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)	Week 12
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Baseline
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Pre-acute resistance exercise bout week 1
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Post-acute resistance exercise bout week 1
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Pre-acute resistance exercise bout week 8
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Post-acute resistance exercise bout week 8
Cognitive Functioning	Stroop Colour and Word Test (Williams et al., 1996)	Week 8
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Baseline
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Pre-acute resistance exercise bout week 1
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Post-acute resistance exercise bout week 1
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Pre-acute resistance exercise bout week 8
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Post-acute resistance exercise bout week 8
Cognitive Functioning	Trail Making Test (Tombaugh, 2004)	Week 8
Resistance Exercise Expectations	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".	Baseline
Resistance Exercise Expectations	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".	Week 1
Resistance Exercise Expectations	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".	Week 4
Resistance Exercise Expectations	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".	Week 8
Resistance Exercise Expectations	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".	Week 12
Resistance Exercise Expectations	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".	Pre-acute resistance exercise bout week 1
Resistance Exercise Expectations	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".	Post-acute resistance exercise bout week 1
Resistance Exercise Expectations	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".	Pre-acute resistance exercise bout week 8
Resistance Exercise Expectations	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".	Post-acute resistance exercise bout week 8
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Baseline
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Pre-week 1
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 1
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 2
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 3
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 4
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 5
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 6
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 7
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 8
Physical Activity	7-day Physical Activity Recall (Blair et al., 1985)	Week 12
Muscle-Strengthening Exercise Activity	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)	Baseline
Muscle-Strengthening Exercise Activity	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)	Week 1
Muscle-Strengthening Exercise Activity	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)	Week 4
Muscle-Strengthening Exercise Activity	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)	Week 8
Muscle-Strengthening Exercise Activity	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)	Week 12

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: Taighde Éireann - Research Ireland
• Investigators: Principal Investigator: Matthew P. Herring, PhD, University of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): January 5, 2025
• Study Completion (Actual): January 5, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Female; Young adults; Resistance training; Strength training; Worry; Analogue Generalized Anxiety Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2017_03_18_EHS_new; GOIPG/2023/4158 (Other Grant/Funding Number: Taighde Éireann - Research Ireland)

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; SAP; 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
• product manufactured in and exported from the U.S.: No