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The Resistance Exercise Training for Worry Trial: Replication and Expansion

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06804629
Acronym
RETRAIN REP-EX
Enrollment
68
Registered
2025-02-03
Start date
2023-10-09
Completion date
2025-01-05
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analogue Generalized Anxiety Disorder

Keywords

Analogue Generalized Anxiety Disorder, Young adults, Female, Worry, Strength training, Resistance training

Brief summary

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.

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.

Interventions

BEHAVIORALModerate-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.

BEHAVIORALLow 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.

Sponsors

Taighde Éireann - Research Ireland
CollaboratorUNKNOWN
University of Limerick
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The principal investigator was blinded to group allocation and performed blinded outcome analyses. Blinding of the investigators who supervised the resistance exercise training sessions was not possible. Participants were not informed of whether they were randomized to an intervention or control group, or of the study hypothesis. At baseline, each participant received an identification number which remained the same throughout the trial. Information that could potentially identify any participant was removed from the working dataset after full data extraction from Qualtrics, such that participants could not be identified based on personal characteristics.

Intervention model description

Parallel group randomized controlled trial of ten weeks of moderate-to-high compared to low intensity SHAM resistance exercise training among young adult women with analogue Generalized Anxiety Disorder

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analogue Generalized Anxiety Disorder StatusBaselinePsychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Worry SymptomsBaseline16-item Penn State Worry Questionnaire (Meyer et al., 1990)

Secondary

MeasureTime frameDescription
MoodBaselineSubscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Analogue Major Depressive Disorder StatusBaselinePsychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Analogue Panic Disorder StatusBaselinePsychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Analogue Social Anxiety Disorder StatusBaselinePsychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Sleep QualityBaselinePittsburgh Sleep Quality Index (Buysse et al., 1989)
Anxiety SymptomsBaselineTrait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
RuminationBaselineRumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Cognitive FunctioningBaselineStroop Colour and Word Test (Williams et al., 1996)
Resistance Exercise ExpectationsBaseline15-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.
Physical ActivityBaseline7-day Physical Activity Recall (Blair et al., 1985)
Muscle-Strengthening Exercise ActivityBaselineMuscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Irritability SymptomsBaseline21-item Irritability Questionnaire (Craig et al., 2008)
Depressive SymptomsBaseline16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026