Clinical trial NCT06629883: Resistance Exercise and Peer Support with Bands/balls and Digital Support Among Women with Polycystic Ovary Syndrome
Official title: Personalized Resistance Training with Peer Support for Women with PCOS Using a Smart Home Video Device: Feasibility Study Guided by Self-Determination Theory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: polycystic ovary syndrome
motivation
resistance training
digital technology
proof of concept study
feasibility studies
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this one arm pilot was to assess the feasibility and acceptability of REPS w/BANDS and evaluate for signals of improvement for depressive symptoms, anthropometrics, and muscular endurance. Participants completed a 12-week personalized in-home resistance exercise program that was delivered in real-time via a smart home video device along with a buddy system for peer support.

Detailed description: Research findings reveal that women with polycystic ovary syndrome (PCOS) report low exercise motivation due to PCOS stigma-related stress and lack of social connection, thus inhibiting exercise in public and group settings. The purpose of this study was to implement and assess the feasibility and acceptability of an in-home personalized resistance exercise (RE) program delivered in real time by a smart home video device (SHVD) with peer support provided by a buddy system. This theory-informed, one-arm proof-of-concept study provided participants (n=10) with an SHVD, exercise equipment (exercise bands, stability ball), and 2 supervised RE sessions per week for 12 weeks via the SHVD's video feature and incorporated strategies from self-determination theory to meet the psychological needs of autonomy, competence, and relatedness. Participants were randomly paired with a buddy. Feasibility, acceptability, depressive symptoms, anthropometrics, and muscular endurance were measured using surveys, fitness testing, and interviews. Quantitative data were calculated using t-tests. Qualitative data were analyzed via thematic analysis.

Eligibility criteria: Inclusion Criteria:

* an age of 18 or older
* a confirmed PCOS diagnosis by a healthcare provider
* physical activity readiness as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
* residence within driving distance of the main university campus.

Exclusion Criteria:

* cardiorespiratory disease (e.g., congestive heart failure)
* hypertension
* orthopedic injury (e.g., herniated disc)
* pregnancy.

Primary outcomes:
measure: Recruitment
timeFrame: At the end of 12 weeks
measure: Attendance
timeFrame: At the end of 12 weeks
measure: Retention
timeFrame: At the end of 12 weeks
measure: Acceptability Interviews
timeFrame: At the end of 12 weeks
measure: Acceptability Likert Scales
timeFrame: At the end of 12 weeks
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: From baseline and at the end of 12 weeks
measure: Bodyweight
timeFrame: At baseline and at the end of 12 weeks
measure: Height
timeFrame: At baseline and at the end of 12 weeks
measure: Waist Circumference
timeFrame: At baseline and at the end of 12 weeks
measure: Squat Test
timeFrame: At baseline and at the end of 12 weeks
measure: Modified Push Up Test
timeFrame: At baseline and at the end of 12 weeks
measure: Curl Up Test
timeFrame: At baseline and at the end of 12 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Clinical Exercise Research Center
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Pamela J Wright, PhD, MS, MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. doi: 10.70252/NEEX8658. eCollection 2021.
citation: Behboodi Moghadam Z, Fereidooni B, Saffari M, Montazeri A. Measures of health-related quality of life in PCOS women: a systematic review. Int J Womens Health. 2018 Aug 1;10:397-408. doi: 10.2147/IJWH.S165794. eCollection 2018.
citation: Legro RS, Arslanian SA, Ehrmann DA, Hoeger KM, Murad MH, Pasquali R, Welt CK; Endocrine Society. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013 Dec;98(12):4565-92. doi: 10.1210/jc.2013-2350. Epub 2013 Oct 22.
citation: Azziz R. Epidemiology and pathogenesis of the polycystic ovary syndrome in adults. 2020. http://www.uptodate.com/contents/epidemiology-and-pathogenesis-of-the-polycysticovary-syndrome/