The Resistance Exercise Training for Worry Trial

NCT04116944 | Completed

• 1 other identifier: 2017_03_18_EHS
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analogue Generalized Anxiety Disorder

Keywords

anxiety

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (69)

• Anxiety Symptoms

  Baseline

• Anxiety Symptoms

  week 1

• Anxiety Symptoms

  week 2

• Anxiety Symptoms

  week 3

• Anxiety Symptoms

  week 4

Study Arms (4)

Analogue-Generalized Anxiety Disorder Resistance Training

EXPERIMENTAL

Resistance exercise training among young adults with analogue-Generalized Anxiety Disorder

Behavioral: Resistance exercise training

Analogue-Generalized Anxiety Disorder Wait-List

OTHER

8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder

Other: Wait-list

Non-Analogue-Generalized Anxiety Disorder Resistance Training

EXPERIMENTAL

Resistance exercise training among young adults without analogue-Generalized Anxiety Disorder

Behavioral: Resistance exercise training

Non-Analogue-Generalized Anxiety Disorder Wait-List

OTHER

8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder

Other: Wait-list

Interventions

Resistance exercise training BEHAVIORAL

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.

Also known as: weight-lifting, strength training

Analogue-Generalized Anxiety Disorder Resistance Training; Non-Analogue-Generalized Anxiety Disorder Resistance Training

Wait-list OTHER

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.

Analogue-Generalized Anxiety Disorder Wait-List; Non-Analogue-Generalized Anxiety Disorder Wait-List

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Limerick: lead
• Irish Research Council: collaborator

Study Sites (1)

The Department of Physical Education and Sport Sciences Building

Limerick, Ireland

Location

Related Publications (3)

• O'Sullivan D, Gordon BR, Lyons M, Meyer JD, Herring MP. Effects of Resistance Exercise on Depressed Mood State: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Nov 1;57(11):2496-2502. doi: 10.1249/MSS.0000000000003769. Epub 2025 May 29.

  PMID: 40440519 DERIVED

• 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.

  PMID: 34801607 DERIVED

• 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.

  PMID: 33067493 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Resistance Training; Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders

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; Appointments and Schedules; Organization and Administration; Health Services Administration

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 participant allocation, and the analyses were performed blinded to group. Participants' individual identification numbers assigned at baseline were used during the course of the trial. Following full data extraction from SurveyMonkey.com, identifying information were removed, such that no participant could be identified in the working dataset through one, or a combination of different variables.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: January 18, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

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)