Acute and Chronic Effects of Guidelines-Based Progressive Resistance Exercise Training Compared to a Low-Intensity Sham Attention-Control on Signs and Symptoms among Young Adult Women With Analogue Generalized Anxiety Disorder: Design and Methods of a Randomized Controlled Trial.

Background: Recent evidence supports the positive effects of moderate-to-high-intensity, guidelines-based, progressive resistance exercise training (PRET) compared to waitlist controls among young adults with analogue Generalized Anxiety Disorder (AGAD). The true effects of PRET independent of potential social and psychological benefits of intervention engagement remain unclear. This 10-week randomized controlled trial (RCT) controls for such benefits by quantifying the acute and chronic effects of eight weeks of PRET compared to a low-intensity sham attention-control (SHAM) on GAD symptoms among young women (18-40y) with AGAD.

Methods: The full design and methods of this 10-week RCT are presented herein. Validated cut-scores on both the Psychiatric Diagnostic Screening Questionnaire GAD subscale (≥6) and the Penn State Worry Questionnaire (≥45) determined AGAD status. PRET was consistent with World Health Organisation and American College of Sports Medicine guidelines; participants performed two sets of 8-12 repetitions of eight exercises at 70-80% one-repetition maximum (1RM). SHAM (20% 1RM) was matched on all intervention features aside from load/intensity. AGAD status and worry severity (primary outcomes) were assessed at baseline, post-two-week familiarization, week 4, week 8, and one-month follow-up. Secondary outcomes were assessed weekly. Two acute resistance exercise trials were nested at weeks one and eight to quantify acute response and potential training-induced changes in acute response.

Conclusion: This 10-week RCT advances knowledge by anticipated replication of the effects of guidelines-based PRET among young women with AGAD, investigation of a minimally-beneficial dose threshold (i.e., low-intensity SHAM) and dose-response, and control of plausible social and psychological influences of intervention engagement.