The Resistance Exercise Training for Worry Trial: Replication and Expansion

NCT06804629 | Completed

• 2 other identifiers: 2017_03_18_EHS_newGOIPG/2023/4158
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Analogue Generalized Anxiety Disorder

Keywords

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

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (109)

• Anxiety Symptoms

  Baseline

• Anxiety Symptoms

  Pre-week 1

• Anxiety Symptoms

  Week 1

• Anxiety Symptoms

  Week 2

• Anxiety Symptoms

  Week 3

Study Arms (2)

Moderate-to-High Intensity Resistance Exercise Training

EXPERIMENTAL

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

Low Intensity SHAM Resistance Exercise Training Attention Control

SHAM COMPARATOR

Low intensity SHAM Resistance Exercise Training completed at 20% of the estimated one-repetition maximum

Behavioral: Low Intensity SHAM Resistance Exercise Training Attention Control

Interventions

Moderate-to-High Intensity Resistance Exercise Training BEHAVIORAL

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.

Also known as: Strength training, Weight-lifting

Moderate-to-High Intensity Resistance Exercise Training

Low Intensity SHAM Resistance Exercise Training Attention Control BEHAVIORAL

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.

Low Intensity SHAM Resistance Exercise Training Attention Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Limerick: lead
• Taighde Éireann - Research Ireland: collaborator

Study Sites (1)

University of Limerick

Limerick, Munster, V94 T9PX, Ireland

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthew P. Herring, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 3, 2025
• Study Start: October 9, 2023
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Proposals should be directed to matthew.herring@ul.ie. To gain access, data requestors will need to sign a data access agreement.

Locations

IE (1)