Clinical trial NCT06804629: The Resistance Exercise Training for Worry Trial: Replication and Expansion
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analogue Generalized Anxiety Disorder
Keywords: Analogue Generalized Anxiety Disorder
Young adults
Female
Worry
Strength training
Resistance training
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Taighde Éireann - Research Ireland
First posted: 2025-02-03
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Baseline
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 1
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 4
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 8
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 12
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Baseline
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 1
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 4
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 8
measure: Analogue Generalized Anxiety Disorder Status
timeFrame: Week 12
measure: Worry Symptoms
timeFrame: Baseline
measure: Worry Symptoms
timeFrame: Pre-week 1
measure: Worry Symptoms
timeFrame: Week 1
measure: Worry Symptoms
timeFrame: Week 2
measure: Worry Symptoms
timeFrame: Week 3
measure: Worry Symptoms
timeFrame: Week 4
measure: Worry Symptoms
timeFrame: Week 5
measure: Worry Symptoms
timeFrame: Week 6
measure: Worry Symptoms
timeFrame: Week 7
measure: Worry Symptoms
timeFrame: Week 8
measure: Worry Symptoms
timeFrame: Week 12
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: Baseline
measure: Anxiety Symptoms
timeFrame: Pre-week 1
measure: Anxiety Symptoms
timeFrame: Week 1
measure: Anxiety Symptoms
timeFrame: Week 2
measure: Anxiety Symptoms
timeFrame: Week 3
measure: Anxiety Symptoms
timeFrame: Week 4
measure: Anxiety Symptoms
timeFrame: Week 5
measure: Anxiety Symptoms
timeFrame: Week 6
measure: Anxiety Symptoms
timeFrame: Week 7
measure: Anxiety Symptoms
timeFrame: Week 8
measure: Anxiety Symptoms
timeFrame: Week 12
measure: Anxiety Symptoms
timeFrame: Baseline
measure: Anxiety Symptoms
timeFrame: Pre-acute resistance exercise bout week 1
measure: Anxiety Symptoms
timeFrame: Post-acute resistance exercise bout week 1
measure: Anxiety Symptoms
timeFrame: Pre-acute resistance exercise bout week 8
measure: Anxiety Symptoms
timeFrame: Post-acute resistance exercise bout week 8
measure: Depressive Symptoms
timeFrame: Baseline
measure: Depressive Symptoms
timeFrame: Pre-week 1
measure: Depressive Symptoms
timeFrame: Week 1
measure: Depressive Symptoms
timeFrame: Week 2
measure: Depressive Symptoms
timeFrame: Week 3
measure: Depressive Symptoms
timeFrame: Week 4
measure: Depressive Symptoms
timeFrame: Week 5
measure: Depressive Symptoms
timeFrame: Week 6
measure: Depressive Symptoms
timeFrame: Week 7
measure: Depressive Symptoms
timeFrame: Week 8
measure: Depressive Symptoms
timeFrame: Week 12
measure: Mood
timeFrame: Baseline
measure: Mood
timeFrame: Pre-week 1
measure: Mood
timeFrame: Week 1
measure: Mood
timeFrame: Week 2
measure: Mood
timeFrame: Week 3
measure: Mood
timeFrame: Week 4
measure: Mood
timeFrame: Week 5
measure: Mood
timeFrame: Week 6
measure: Mood
timeFrame: Week 7
measure: Mood
timeFrame: Week 8
measure: Mood
timeFrame: Week 12
measure: Mood
timeFrame: Pre-acute resistance exercise bout week 1
measure: Mood
timeFrame: Post-acute resistance exercise bout week 1
measure: Mood
timeFrame: Pre-acute resistance exercise bout week 8
measure: Mood
timeFrame: Post-acute resistance exercise bout week 8
measure: Analogue Major Depressive Disorder Status
timeFrame: Baseline
measure: Analogue Major Depressive Disorder Status
timeFrame: Week 1
measure: Analogue Major Depressive Disorder Status
timeFrame: Week 4
measure: Analogue Major Depressive Disorder Status
timeFrame: Week 8
measure: Analogue Major Depressive Disorder Status
timeFrame: Week 12
measure: Analogue Panic Disorder Status
timeFrame: Baseline
measure: Analogue Panic Disorder Status
timeFrame: Week 1
measure: Analogue Panic Disorder Status
timeFrame: Week 4
measure: Analogue Panic Disorder Status
timeFrame: Week 8
measure: Analogue Panic Disorder Status
timeFrame: Week 12
measure: Analogue Social Anxiety Disorder Status
timeFrame: Baseline
measure: Analogue Social Anxiety Disorder Status
timeFrame: Week 1
measure: Analogue Social Anxiety Disorder Status
timeFrame: Week 4
measure: Analogue Social Anxiety Disorder Status
timeFrame: Week 8
measure: Analogue Social Anxiety Disorder Status
timeFrame: Week 12
measure: Sleep Quality
timeFrame: Baseline
measure: Sleep Quality
timeFrame: Week 1
measure: Sleep Quality
timeFrame: Week 4
measure: Sleep Quality
timeFrame: Week 8
measure: Sleep Quality
timeFrame: Week 12
measure: Irritability Symptoms
timeFrame: Baseline
measure: Irritability Symptoms
timeFrame: Week 1
measure: Irritability Symptoms
timeFrame: Week 4
measure: Irritability Symptoms
timeFrame: Week 8
measure: Irritability Symptoms
timeFrame: Week 12
measure: Rumination
timeFrame: Baseline
measure: Rumination
timeFrame: Week 1
measure: Rumination
timeFrame: Week 4
measure: Rumination
timeFrame: Week 8
measure: Rumination
timeFrame: Week 12
measure: Cognitive Functioning
timeFrame: Baseline
measure: Cognitive Functioning
timeFrame: Pre-acute resistance exercise bout week 1
measure: Cognitive Functioning
timeFrame: Post-acute resistance exercise bout week 1
measure: Cognitive Functioning
timeFrame: Pre-acute resistance exercise bout week 8
measure: Cognitive Functioning
timeFrame: Post-acute resistance exercise bout week 8
measure: Cognitive Functioning
timeFrame: Week 8
measure: Cognitive Functioning
timeFrame: Baseline
measure: Cognitive Functioning
timeFrame: Pre-acute resistance exercise bout week 1
measure: Cognitive Functioning
timeFrame: Post-acute resistance exercise bout week 1
measure: Cognitive Functioning
timeFrame: Pre-acute resistance exercise bout week 8
measure: Cognitive Functioning
timeFrame: Post-acute resistance exercise bout week 8
measure: Cognitive Functioning
timeFrame: Week 8
measure: Resistance Exercise Expectations
timeFrame: Baseline
measure: Resistance Exercise Expectations
timeFrame: Week 1
measure: Resistance Exercise Expectations
timeFrame: Week 4
measure: Resistance Exercise Expectations
timeFrame: Week 8
measure: Resistance Exercise Expectations
timeFrame: Week 12
measure: Resistance Exercise Expectations
timeFrame: Pre-acute resistance exercise bout week 1
measure: Resistance Exercise Expectations
timeFrame: Post-acute resistance exercise bout week 1
measure: Resistance Exercise Expectations
timeFrame: Pre-acute resistance exercise bout week 8
measure: Resistance Exercise Expectations
timeFrame: Post-acute resistance exercise bout week 8
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: Pre-week 1
measure: Physical Activity
timeFrame: Week 1
measure: Physical Activity
timeFrame: Week 2
measure: Physical Activity
timeFrame: Week 3
measure: Physical Activity
timeFrame: Week 4
measure: Physical Activity
timeFrame: Week 5
measure: Physical Activity
timeFrame: Week 6
measure: Physical Activity
timeFrame: Week 7
measure: Physical Activity
timeFrame: Week 8
measure: Physical Activity
timeFrame: Week 12
measure: Muscle-Strengthening Exercise Activity
timeFrame: Baseline
measure: Muscle-Strengthening Exercise Activity
timeFrame: Week 1
measure: Muscle-Strengthening Exercise Activity
timeFrame: Week 4
measure: Muscle-Strengthening Exercise Activity
timeFrame: Week 8
measure: Muscle-Strengthening Exercise Activity
timeFrame: Week 12
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
state: Munster
Study officials:
affiliation: University of Limerick
name: Matthew P. Herring, PhD
role: PRINCIPAL_INVESTIGATOR
References: