The Resistance Exercise Training for Worry Trial: Replication and Expansion (RETRAIN REP-EX)

January 27, 2025 updated by: University of Limerick

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Limerick, Munster, Ireland, V94 T9PX
        • University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Behavioral: Moderate-to-High Intensity Resistance Exercise Training
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.
Other Names:
  • Strength training
  • Weight-lifting
Sham Comparator: Low Intensity SHAM Resistance Exercise Training Attention Control
Low intensity SHAM Resistance Exercise Training completed at 20% of the estimated one-repetition maximum
Behavioral: Low Intensity SHAM Resistance Exercise Training Attention Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analogue Generalized Anxiety Disorder Status
Time Frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001)
Baseline
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)
Week 1
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)
Week 4
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)
Week 8
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)
Week 12
Analogue Generalized Anxiety Disorder Status
Time Frame: Baseline
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Baseline
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 1
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Week 1
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 4
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Week 4
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 8
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Week 8
Analogue Generalized Anxiety Disorder Status
Time Frame: Week 12
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Week 12
Worry Symptoms
Time Frame: Baseline
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Baseline
Worry Symptoms
Time Frame: Pre-week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Pre-week 1
Worry Symptoms
Time Frame: Week 1
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 1
Worry Symptoms
Time Frame: Week 2
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 2
Worry Symptoms
Time Frame: Week 3
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 3
Worry Symptoms
Time Frame: Week 4
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 4
Worry Symptoms
Time Frame: Week 5
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 5
Worry Symptoms
Time Frame: Week 6
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 6
Worry Symptoms
Time Frame: Week 7
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 7
Worry Symptoms
Time Frame: Week 8
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 8
Worry Symptoms
Time Frame: Week 12
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Baseline
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Baseline
Mood
Time Frame: Week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 1
Mood
Time Frame: Week 2
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 2
Mood
Time Frame: Week 3
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 3
Mood
Time Frame: Week 4
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 4
Mood
Time Frame: Week 5
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 5
Mood
Time Frame: Week 6
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 6
Mood
Time Frame: Week 7
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 7
Mood
Time Frame: Week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 8
Anxiety Symptoms
Time Frame: Baseline
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Baseline
Anxiety Symptoms
Time Frame: Pre-week 1
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Pre-week 1
Anxiety Symptoms
Time Frame: Week 1
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 1
Anxiety Symptoms
Time Frame: Week 2
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 2
Anxiety Symptoms
Time Frame: Week 3
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 3
Anxiety Symptoms
Time Frame: Week 4
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 4
Anxiety Symptoms
Time Frame: Week 5
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 5
Anxiety Symptoms
Time Frame: Week 6
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 6
Anxiety Symptoms
Time Frame: Week 7
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 7
Anxiety Symptoms
Time Frame: Week 8
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 8
Anxiety Symptoms
Time Frame: Week 12
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Week 12
Anxiety Symptoms
Time Frame: Baseline
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Baseline
Anxiety Symptoms
Time Frame: Pre-acute resistance exercise bout week 1
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Pre-acute resistance exercise bout week 1
Anxiety Symptoms
Time Frame: Post-acute resistance exercise bout week 1
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Post-acute resistance exercise bout week 1
Anxiety Symptoms
Time Frame: Pre-acute resistance exercise bout week 8
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Pre-acute resistance exercise bout week 8
Anxiety Symptoms
Time Frame: Post-acute resistance exercise bout week 8
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Post-acute resistance exercise bout week 8
Depressive Symptoms
Time Frame: Baseline
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Baseline
Depressive Symptoms
Time Frame: Pre-week 1
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Pre-week 1
Depressive Symptoms
Time Frame: Week 1
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 1
Depressive Symptoms
Time Frame: Week 2
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 2
Depressive Symptoms
Time Frame: Week 3
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 3
Depressive Symptoms
Time Frame: Week 4
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 4
Depressive Symptoms
Time Frame: Week 5
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 5
Depressive Symptoms
Time Frame: Week 6
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 6
Depressive Symptoms
Time Frame: Week 7
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 7
Depressive Symptoms
Time Frame: Week 8
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 8
Depressive Symptoms
Time Frame: Week 12
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Week 12
Mood
Time Frame: Pre-week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Pre-week 1
Mood
Time Frame: Week 12
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Week 12
Mood
Time Frame: Pre-acute resistance exercise bout week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Pre-acute resistance exercise bout week 1
Mood
Time Frame: Post-acute resistance exercise bout week 1
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Post-acute resistance exercise bout week 1
Mood
Time Frame: Pre-acute resistance exercise bout week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Pre-acute resistance exercise bout week 8
Mood
Time Frame: Post-acute resistance exercise bout week 8
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Post-acute resistance exercise bout week 8
Analogue Major Depressive Disorder Status
Time Frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Baseline
Analogue Major Depressive Disorder Status
Time Frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Week 1
Analogue Major Depressive Disorder Status
Time Frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Week 4
Analogue Major Depressive Disorder Status
Time Frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Week 8
Analogue Major Depressive Disorder Status
Time Frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman & Mattia, 2001)
Week 12
Analogue Panic Disorder Status
Time Frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Baseline
Analogue Panic Disorder Status
Time Frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 1
Analogue Panic Disorder Status
Time Frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 4
Analogue Panic Disorder Status
Time Frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 8
Analogue Panic Disorder Status
Time Frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 12
Analogue Social Anxiety Disorder Status
Time Frame: Baseline
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Baseline
Analogue Social Anxiety Disorder Status
Time Frame: Week 1
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 1
Analogue Social Anxiety Disorder Status
Time Frame: Week 4
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 4
Analogue Social Anxiety Disorder Status
Time Frame: Week 8
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 8
Analogue Social Anxiety Disorder Status
Time Frame: Week 12
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman & Mattia, 2001)
Week 12
Sleep Quality
Time Frame: Baseline
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Baseline
Sleep Quality
Time Frame: Week 1
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Week 1
Sleep Quality
Time Frame: Week 4
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Week 4
Sleep Quality
Time Frame: Week 8
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Week 8
Sleep Quality
Time Frame: Week 12
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Week 12
Irritability Symptoms
Time Frame: Baseline
21-item Irritability Questionnaire (Craig et al., 2008)
Baseline
Irritability Symptoms
Time Frame: Week 1
21-item Irritability Questionnaire (Craig et al., 2008)
Week 1
Irritability Symptoms
Time Frame: Week 4
21-item Irritability Questionnaire (Craig et al., 2008)
Week 4
Irritability Symptoms
Time Frame: Week 8
21-item Irritability Questionnaire (Craig et al., 2008)
Week 8
Irritability Symptoms
Time Frame: Week 12
21-item Irritability Questionnaire (Craig et al., 2008)
Week 12
Rumination
Time Frame: Baseline
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Baseline
Rumination
Time Frame: Week 1
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Week 1
Rumination
Time Frame: Week 4
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Week 4
Rumination
Time Frame: Week 8
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Week 8
Rumination
Time Frame: Week 12
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Week 12
Cognitive Functioning
Time Frame: Baseline
Stroop Colour and Word Test (Williams et al., 1996)
Baseline
Cognitive Functioning
Time Frame: Pre-acute resistance exercise bout week 1
Stroop Colour and Word Test (Williams et al., 1996)
Pre-acute resistance exercise bout week 1
Cognitive Functioning
Time Frame: Post-acute resistance exercise bout week 1
Stroop Colour and Word Test (Williams et al., 1996)
Post-acute resistance exercise bout week 1
Cognitive Functioning
Time Frame: Pre-acute resistance exercise bout week 8
Stroop Colour and Word Test (Williams et al., 1996)
Pre-acute resistance exercise bout week 8
Cognitive Functioning
Time Frame: Post-acute resistance exercise bout week 8
Stroop Colour and Word Test (Williams et al., 1996)
Post-acute resistance exercise bout week 8
Cognitive Functioning
Time Frame: Week 8
Stroop Colour and Word Test (Williams et al., 1996)
Week 8
Cognitive Functioning
Time Frame: Baseline
Trail Making Test (Tombaugh, 2004)
Baseline
Cognitive Functioning
Time Frame: Pre-acute resistance exercise bout week 1
Trail Making Test (Tombaugh, 2004)
Pre-acute resistance exercise bout week 1
Cognitive Functioning
Time Frame: Post-acute resistance exercise bout week 1
Trail Making Test (Tombaugh, 2004)
Post-acute resistance exercise bout week 1
Cognitive Functioning
Time Frame: Pre-acute resistance exercise bout week 8
Trail Making Test (Tombaugh, 2004)
Pre-acute resistance exercise bout week 8
Cognitive Functioning
Time Frame: Post-acute resistance exercise bout week 8
Trail Making Test (Tombaugh, 2004)
Post-acute resistance exercise bout week 8
Cognitive Functioning
Time Frame: Week 8
Trail Making Test (Tombaugh, 2004)
Week 8
Resistance Exercise Expectations
Time Frame: Baseline
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".
Baseline
Resistance Exercise Expectations
Time Frame: Week 1
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".
Week 1
Resistance Exercise Expectations
Time Frame: Week 4
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".
Week 4
Resistance Exercise Expectations
Time Frame: Week 8
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".
Week 8
Resistance Exercise Expectations
Time Frame: Week 12
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".
Week 12
Resistance Exercise Expectations
Time Frame: Pre-acute resistance exercise bout week 1
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".
Pre-acute resistance exercise bout week 1
Resistance Exercise Expectations
Time Frame: Post-acute resistance exercise bout week 1
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".
Post-acute resistance exercise bout week 1
Resistance Exercise Expectations
Time Frame: Pre-acute resistance exercise bout week 8
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".
Pre-acute resistance exercise bout week 8
Resistance Exercise Expectations
Time Frame: Post-acute resistance exercise bout week 8
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".
Post-acute resistance exercise bout week 8
Physical Activity
Time Frame: Baseline
7-day Physical Activity Recall (Blair et al., 1985)
Baseline
Physical Activity
Time Frame: Pre-week 1
7-day Physical Activity Recall (Blair et al., 1985)
Pre-week 1
Physical Activity
Time Frame: Week 1
7-day Physical Activity Recall (Blair et al., 1985)
Week 1
Physical Activity
Time Frame: Week 2
7-day Physical Activity Recall (Blair et al., 1985)
Week 2
Physical Activity
Time Frame: Week 3
7-day Physical Activity Recall (Blair et al., 1985)
Week 3
Physical Activity
Time Frame: Week 4
7-day Physical Activity Recall (Blair et al., 1985)
Week 4
Physical Activity
Time Frame: Week 5
7-day Physical Activity Recall (Blair et al., 1985)
Week 5
Physical Activity
Time Frame: Week 6
7-day Physical Activity Recall (Blair et al., 1985)
Week 6
Physical Activity
Time Frame: Week 7
7-day Physical Activity Recall (Blair et al., 1985)
Week 7
Physical Activity
Time Frame: Week 8
7-day Physical Activity Recall (Blair et al., 1985)
Week 8
Physical Activity
Time Frame: Week 12
7-day Physical Activity Recall (Blair et al., 1985)
Week 12
Muscle-Strengthening Exercise Activity
Time Frame: Baseline
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Baseline
Muscle-Strengthening Exercise Activity
Time Frame: Week 1
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Week 1
Muscle-Strengthening Exercise Activity
Time Frame: Week 4
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Week 4
Muscle-Strengthening Exercise Activity
Time Frame: Week 8
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Week 8
Muscle-Strengthening Exercise Activity
Time Frame: Week 12
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Limerick

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taighde Éireann - Research Ireland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew P. Herring, PhD, University of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017_03_18_EHS_new
  • GOIPG/2023/4158 (Other Grant/Funding Number: Taighde Éireann - Research Ireland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcomes measures will be made available.

IPD Sharing 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.

IPD Sharing Access Criteria

Proposals should be directed to matthew.herring@ul.ie. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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