Analogue Generalized Anxiety DisorderRETRAIN REP-EXNCT06804629
The Resistance Exercise Training for Worry Trial: Replication and Expansion
A study testing Moderate-to-High Intensity Resistance Exercise Training in people with Analogue Generalized Anxiety Disorder, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Analogue Generalized Anxiety Disorder
- What is being tested?
- Moderate-to-High Intensity Resistance Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteIreland
- Study dates
- 9 Oct 2023to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Aged 18-40y
- Met criteria for analogue Generalized Anxiety Disorder
Who cannot join
- Medical contraindications to doing resistance exercise training
- Currently involved in formal resistance exercise training
- Currently pregnant or post-partum
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Analogue Generalized Anxiety Disorder
- Being tested
- Moderate-to-High Intensity Resistance Exercise Training, Low Intensity SHAM Resistance Exercise Training Attention Control
- Keywords
- Analogue Generalized Anxiety Disorder, Young adults, Female, Worry, Strength training, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-to-High Intensity Resistance Exercise TrainingBehavioural
Also called Strength training, Weight-lifting
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.
Low Intensity SHAM Resistance Exercise Training Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Low Intensity SHAM Resistance Exercise Training Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Measured: Baseline
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 1
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 4
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 8
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 12
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Measured: Baseline
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Measured: Week 1
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Measured: Week 4
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Measured: Week 8
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Measured: Week 12
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Baseline
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Pre-week 1
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 1
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 2
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 3
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 4
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 5
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 6
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 7
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 8
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Measured: Week 12
Secondary outcomes (109)
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Baseline
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Pre-week 1
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 1
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 2
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 3
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 4
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 5
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 6
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 7
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 8
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Week 12
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Baseline
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Pre-acute resistance exercise bout week 1
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Post-acute resistance exercise bout week 1
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Pre-acute resistance exercise bout week 8
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Measured: Post-acute resistance exercise bout week 8
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Baseline
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Pre-week 1
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 1
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 2
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 3
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 4
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 5
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 6
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 7
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 8
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Measured: Week 12
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Baseline
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Pre-week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 2
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 3
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 4
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 5
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 6
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 7
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 8
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Week 12
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Pre-acute resistance exercise bout week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Post-acute resistance exercise bout week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Pre-acute resistance exercise bout week 8
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Measured: Post-acute resistance exercise bout week 8
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Measured: Baseline
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 1
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 4
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 8
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 12
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Baseline
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 1
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 4
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 8
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 12
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Baseline
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 1
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 4
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 8
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Measured: Week 12
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Measured: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Measured: Week 1
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Measured: Week 4
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Measured: Week 8
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Measured: Week 12
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Measured: Baseline
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Measured: Week 1
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Measured: Week 4
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Measured: Week 8
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Measured: Week 12
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Measured: Baseline
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Measured: Week 1
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Measured: Week 4
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Measured: Week 8
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Measured: Week 12
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Baseline
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Pre-acute resistance exercise bout week 1
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Post-acute resistance exercise bout week 1
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Pre-acute resistance exercise bout week 8
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Post-acute resistance exercise bout week 8
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Measured: Week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Baseline
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Pre-acute resistance exercise bout week 1
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Post-acute resistance exercise bout week 1
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Pre-acute resistance exercise bout week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Post-acute resistance exercise bout week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Measured: Week 8
Resistance Exercise Expectations
15-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".
Measured: Baseline
Resistance Exercise Expectations
15-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".
Measured: Week 1
Resistance Exercise Expectations
15-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".
Measured: Week 4
Resistance Exercise Expectations
15-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".
Measured: Week 8
Resistance Exercise Expectations
15-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".
Measured: Week 12
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Measured: Pre-acute resistance exercise bout week 1
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Measured: Post-acute resistance exercise bout week 1
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Measured: Pre-acute resistance exercise bout week 8
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Measured: Post-acute resistance exercise bout week 8
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Baseline
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Pre-week 1
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 1
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 2
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 3
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 4
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 5
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 6
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 7
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 8
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Measured: Week 12
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Measured: Baseline
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Measured: Week 1
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Measured: Week 4
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Measured: Week 8
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start9 Oct 2023
- Primary completion5 Jan 2025
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analogue Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Taighde Éireann - Research Ireland
- Responsible party
- Sponsor
- Investigators
- Matthew P. Herring, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804629
- Sponsor's protocol ID
- 2017_03_18_EHS_new
- Other IDs
- GOIPG/2023/4158
- Acronym
- RETRAIN REP-EX
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06804629
- Acronym / sponsor ID
- RETRAIN REP-EX / 2017_03_18_EHS_new
- Conditions
- Analogue Generalized Anxiety Disorder
- Keywords
- Analogue Generalized Anxiety Disorder, Young adults, Female, Worry, Strength training, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Taighde Éireann - Research Ireland
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-High Intensity Resistance Exercise Training | Experimental | Behavioral: Moderate-to-High Intensity Resistance Exercise TrainingModerate-to-high intensity, guidelines-based resistance exercise training completed at 70-80% of the estimated one-repetition maximum |
| Low Intensity SHAM Resistance Exercise Training Attention Control | Sham comparator | Behavioral: Low Intensity SHAM Resistance Exercise Training Attention ControlLow intensity SHAM Resistance Exercise Training completed at 20% of the estimated one-repetition maximum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Aged 18-40y
- Met criteria for analogue Generalized Anxiety Disorder
Key exclusion criteria (3 listed)
- Medical contraindications to doing resistance exercise training
- Currently involved in formal resistance exercise training
- Currently pregnant or post-partum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-to-High Intensity Resistance Exercise TrainingAlso: Strength training, Weight-liftingResistance 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. | Behavioural | Moderate-to-High Intensity Resistance Exercise Training |
| Low Intensity SHAM Resistance Exercise Training Attention ControlThe 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. | Behavioural | Low Intensity SHAM Resistance Exercise Training Attention Control |
Primary outcome
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)
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)
Analogue Generalized Anxiety Disorder Status
Time frame: Baseline
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Analogue Generalized Anxiety Disorder Status
Time frame: Week 1
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Analogue Generalized Anxiety Disorder Status
Time frame: Week 4
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Analogue Generalized Anxiety Disorder Status
Time frame: Week 8
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Analogue Generalized Anxiety Disorder Status
Time frame: Week 12
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
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)
Worry Symptoms
Time frame: Week 12
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
109 secondary outcomes
Anxiety Symptoms
Time frame: Baseline
Anxiety Symptoms
Time frame: Pre-week 1
Anxiety Symptoms
Time frame: Week 1
Anxiety Symptoms
Time frame: Week 2
Anxiety Symptoms
Time frame: Week 3
Anxiety Symptoms
Time frame: Week 4
Anxiety Symptoms
Time frame: Week 5
Anxiety Symptoms
Time frame: Week 6
Anxiety Symptoms
Time frame: Week 7
Anxiety Symptoms
Time frame: Week 8
Anxiety Symptoms
Time frame: Week 12
Anxiety Symptoms
Time frame: Baseline
Anxiety Symptoms
Time frame: Pre-acute resistance exercise bout week 1
Anxiety Symptoms
Time frame: Post-acute resistance exercise bout week 1
Anxiety Symptoms
Time frame: Pre-acute resistance exercise bout week 8
Anxiety Symptoms
Time frame: Post-acute resistance exercise bout week 8
Depressive Symptoms
Time frame: Baseline
Depressive Symptoms
Time frame: Pre-week 1
Depressive Symptoms
Time frame: Week 1
Depressive Symptoms
Time frame: Week 2
Depressive Symptoms
Time frame: Week 3
Depressive Symptoms
Time frame: Week 4
Depressive Symptoms
Time frame: Week 5
Depressive Symptoms
Time frame: Week 6
Depressive Symptoms
Time frame: Week 7
Depressive Symptoms
Time frame: Week 8
Depressive Symptoms
Time frame: Week 12
Mood
Time frame: Baseline
Mood
Time frame: Pre-week 1
Mood
Time frame: Week 1
Mood
Time frame: Week 2
Mood
Time frame: Week 3
Mood
Time frame: Week 4
Mood
Time frame: Week 5
Mood
Time frame: Week 6
Mood
Time frame: Week 7
Mood
Time frame: Week 8
Mood
Time frame: Week 12
Mood
Time frame: Pre-acute resistance exercise bout week 1
Mood
Time frame: Post-acute resistance exercise bout week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes measures will be made available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew P. Herring, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-to-High Intensity Resistance Exercise Training in people with Analogue Generalized Anxiety Disorder, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analogue Generalized Anxiety Disorder Status (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.