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Completed

NCT Number: NCT06629883

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Exercise Research Center

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment

    Time frame: At the end of 12 weeks

    Screened participants # / Enrolled participants #

  2. Attendance

    Time frame: At the end of 12 weeks

    Session # attended / Session # prescribed

  3. Retention

    Time frame: At the end of 12 weeks

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

  4. Acceptability Interviews

    Time frame: At the end of 12 weeks

    Acceptability was measured via content analysis of participant interviews

  5. Acceptability Likert Scales

    Time frame: At the end of 12 weeks

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

Secondary outcomes

  1. Depressive Symptoms

    Time frame: From baseline and at the end of 12 weeks

    he Personal Health Questionnaire (PHQ-8) was used to assess prevalence and severity of depressive symptoms occurring within the past two weeks. The score is the sum of the 8 items. 0-4 = minimal or no depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-24 = severe depression

  2. Bodyweight

    Time frame: At baseline and at the end of 12 weeks

    Participants self-reported body weight in pounds during the fitness assessments.

  3. Height

    Time frame: At baseline and at the end of 12 weeks

    Participants self-reported height in feet and inches during the fitness assessments.

  4. Waist Circumference

    Time frame: At baseline and at the end of 12 weeks

    Participants were guided to measure waist circumference in inches during the fitness assessments.

  5. Squat Test

    Time frame: At baseline and at the end of 12 weeks

    Lower body muscular endurance was measured using the squat test. The score was the number of squats performed with proper form.

  6. Modified Push Up Test

    Time frame: At baseline and at the end of 12 weeks

    Upper body muscular endurance was measured with this test. The score was the number of correctly performed push-up in one minute.

  7. Curl Up Test

    Time frame: At baseline and at the end of 12 weeks

    This test was used to measure muscular endurance of the core. The score was the number of curl up properly performed to a cadence of 40bpm.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Personalized Resistance Training with Peer Support for Women with PCOS Using a Smart Home Video Device: Feasibility Study Guided by Self-Determination Theory

Acronym: REPS w/BANDS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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