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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Limerick
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Analogue Generalized Anxiety Disorder Status
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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
Intervention: Moderate-to-High Intensity Resistance Exercise Training (Behavioral)
Low Intensity SHAM Resistance Exercise Training Attention Control
Low intensity SHAM Resistance Exercise Training completed at 20% of the estimated one-repetition maximum
Intervention: Low Intensity SHAM Resistance Exercise Training Attention Control (Behavioral)
Outcomes
Primary Outcomes
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Worry Symptoms
Time Frame: Week 12
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Analogue Generalized Anxiety Disorder Status
Time Frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Worry Symptoms
Time Frame: Baseline
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Pre-week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 2
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 3
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 4
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 5
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 6
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 7
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Worry Symptoms
Time Frame: Week 8
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Secondary Outcomes
- Cognitive Functioning(Week 8)
- Anxiety Symptoms(Post-acute resistance exercise bout week 8)
- Depressive Symptoms(Week 12)
- Mood(Post-acute resistance exercise bout week 8)
- Analogue Major Depressive Disorder Status(Week 12)
- Analogue Panic Disorder Status(Week 12)
- Analogue Social Anxiety Disorder Status(Week 12)
- Sleep Quality(Week 12)
- Irritability Symptoms(Week 12)
- Rumination(Week 12)
- Resistance Exercise Expectations(Post-acute resistance exercise bout week 8)
- Physical Activity(Week 12)
- Muscle-Strengthening Exercise Activity(Week 12)
- Mood(Post-acute resistance exercise bout week 1)
- Mood(Pre-acute resistance exercise bout week 8)
- Analogue Major Depressive Disorder Status(Baseline)
- Analogue Major Depressive Disorder Status(Week 1)
- Anxiety Symptoms(Baseline)
- Anxiety Symptoms(Pre-week 1)
- Anxiety Symptoms(Week 1)
- Anxiety Symptoms(Week 2)
- Anxiety Symptoms(Week 3)
- Anxiety Symptoms(Week 4)
- Mood(Week 4)
- Anxiety Symptoms(Week 5)
- Anxiety Symptoms(Week 6)
- Anxiety Symptoms(Week 7)
- Anxiety Symptoms(Week 8)
- Anxiety Symptoms(Week 12)
- Depressive Symptoms(Week 1)
- Depressive Symptoms(Week 2)
- Anxiety Symptoms(Pre-acute resistance exercise bout week 1)
- Anxiety Symptoms(Post-acute resistance exercise bout week 1)
- Anxiety Symptoms(Pre-acute resistance exercise bout week 8)
- Depressive Symptoms(Baseline)
- Depressive Symptoms(Pre-week 1)
- Depressive Symptoms(Week 3)
- Depressive Symptoms(Week 4)
- Depressive Symptoms(Week 5)
- Depressive Symptoms(Week 6)
- Depressive Symptoms(Week 7)
- Depressive Symptoms(Week 8)
- Mood(Baseline)
- Mood(Pre-week 1)
- Mood(Week 1)
- Mood(Week 2)
- Mood(Week 3)
- Mood(Week 5)
- Mood(Week 6)
- Mood(Week 7)
- Mood(Week 8)
- Mood(Week 12)
- Mood(Pre-acute resistance exercise bout week 1)
- Analogue Major Depressive Disorder Status(Week 4)
- Analogue Major Depressive Disorder Status(Week 8)
- Analogue Panic Disorder Status(Baseline)
- Analogue Panic Disorder Status(Week 1)
- Analogue Panic Disorder Status(Week 4)
- Analogue Panic Disorder Status(Week 8)
- Analogue Social Anxiety Disorder Status(Baseline)
- Analogue Social Anxiety Disorder Status(Week 1)
- Analogue Social Anxiety Disorder Status(Week 4)
- Analogue Social Anxiety Disorder Status(Week 8)
- Sleep Quality(Baseline)
- Sleep Quality(Week 1)
- Sleep Quality(Week 4)
- Sleep Quality(Week 8)
- Irritability Symptoms(Baseline)
- Irritability Symptoms(Week 1)
- Irritability Symptoms(Week 4)
- Irritability Symptoms(Week 8)
- Rumination(Baseline)
- Rumination(Week 1)
- Rumination(Week 4)
- Rumination(Week 8)
- Cognitive Functioning(Baseline)
- Cognitive Functioning(Pre-acute resistance exercise bout week 1)
- Cognitive Functioning(Post-acute resistance exercise bout week 1)
- Cognitive Functioning(Pre-acute resistance exercise bout week 8)
- Cognitive Functioning(Post-acute resistance exercise bout week 8)
- Resistance Exercise Expectations(Baseline)
- Resistance Exercise Expectations(Week 1)
- Resistance Exercise Expectations(Week 4)
- Resistance Exercise Expectations(Week 8)
- Resistance Exercise Expectations(Week 12)
- Physical Activity(Week 1)
- Resistance Exercise Expectations(Pre-acute resistance exercise bout week 1)
- Resistance Exercise Expectations(Post-acute resistance exercise bout week 1)
- Resistance Exercise Expectations(Pre-acute resistance exercise bout week 8)
- Physical Activity(Baseline)
- Physical Activity(Pre-week 1)
- Physical Activity(Week 2)
- Physical Activity(Week 3)
- Physical Activity(Week 4)
- Physical Activity(Week 5)
- Physical Activity(Week 6)
- Physical Activity(Week 7)
- Physical Activity(Week 8)
- Muscle-Strengthening Exercise Activity(Baseline)
- Muscle-Strengthening Exercise Activity(Week 1)
- Muscle-Strengthening Exercise Activity(Week 4)
- Muscle-Strengthening Exercise Activity(Week 8)