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

NCT ID: NCT06629883

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome (PCOS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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REPS w/BANDS

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.

Group Type EXPERIMENTAL

REPS w/BANDS

Intervention Type 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.

Interventions

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REPS w/BANDS

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Pamela J. Wright

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela J Wright, PhD, MS, MEd

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Clinical Exercise Research Center

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34567361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30123008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24151290 (View on PubMed)

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/

Reference Type BACKGROUND

Other Identifiers

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Pro00120540

Identifier Type: -

Identifier Source: org_study_id

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