Resistance Exercise and Peer Support with Bands/balls and Digital Support Among Women with Polycystic Ovary Syndrome

NCT06629883 | Completed

• 1 other identifier: Pro00120540
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

polycystic ovary syndrome; motivation; resistance training; digital technology; proof of concept study; feasibility studies

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Screened participants # / Enrolled participants #

  At the end of 12 weeks

• Attendance

  Session # attended / Session # prescribed

  At the end of 12 weeks

• Retention

  Participant # completing 2nd assessment / Participant # completing baseline assessment

  At the end of 12 weeks

• Acceptability Interviews

  Acceptability was measured via content analysis of participant interviews

  At the end of 12 weeks

• Acceptability Likert Scales

  Questions of about satisfaction with REPS w/BANDS were scored on a scale of 0-4, with O indicating poor and 4 indicating excellent.

  At the end of 12 weeks

Secondary Outcomes (7)

• Depressive Symptoms

  From baseline and at the end of 12 weeks

• Bodyweight

  At baseline and at the end of 12 weeks

• Height

  At baseline and at the end of 12 weeks

• Waist Circumference

  At baseline and at the end of 12 weeks

• Squat Test

  At baseline and at the end of 12 weeks

Study Arms (1)

REPS w/BANDS

EXPERIMENTAL

The intervention was delivered by certified personal trainers who connected with participants in their homes using SHVDs. Supervised training was individually delivered to participants in real time and incorporated low-cost, portable resistance equipment (i.e., resistance bands, stability ball). SDT-guided strategies (e.g., peer support, practice, encouragement, affirmations) were incorporated to help increase exercise motivation. Peer support was addressed by randomly assigning participants with a buddy. Personal trainers demonstrated proper exercise form and had participants practice each exercise. Participants were instructed on how to use an affirmation app on the SHVD and encouraged to use it at least weekly.

Behavioral: REPS w/BANDS

Interventions

REPS w/BANDS BEHAVIORAL

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.

REPS w/BANDS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

Clinical Exercise Research Center

Columbia, South Carolina, 29208, United States

Location

Related Publications (4)

• 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.

  PMID: 34567361 BACKGROUND

• 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.

  PMID: 30123008 BACKGROUND

• 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.

  PMID: 24151290 BACKGROUND

• 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/

  BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Pamela J Wright, PhD, MS, MEd

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: June 1, 2022
• Primary Completion: February 15, 2023
• Study Completion: May 31, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)