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Polycystic Ovary Syndrome (PCOS)REPS w/BANDSNCT06629883

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

A study testing REPS w/BANDS in people with Polycystic Ovary Syndrome (PCOS), run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
REPS w/BANDS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Exercise Research Center

    Columbia, South Carolina, 29208

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
REPS w/BANDS
Keywords
polycystic ovary syndrome, motivation, resistance training, digital technology, proof of concept study, feasibility studies
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REPS w/BANDSBehavioural

    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.

Study groups in NCT06629883
Study groupRoleWhat they receive
REPS w/BANDSExperimentalThe 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.
Receives: Behavioral: REPS w/BANDS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Screened participants # / Enrolled participants #

    Measured: At the end of 12 weeks

  2. Attendance

    Session # attended / Session # prescribed

    Measured: At the end of 12 weeks

  3. Retention

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

    Measured: At the end of 12 weeks

  4. Acceptability Interviews

    Acceptability was measured via content analysis of participant interviews

    Measured: At the end of 12 weeks

  5. 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.

    Measured: At the end of 12 weeks

Secondary outcomes (7)

  1. Depressive Symptoms

    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

    Measured: From baseline and at the end of 12 weeks

  2. Bodyweight

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

    Measured: At baseline and at the end of 12 weeks

  3. Height

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

    Measured: At baseline and at the end of 12 weeks

  4. Waist Circumference

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

    Measured: At baseline and at the end of 12 weeks

  5. Squat Test

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

    Measured: At baseline and at the end of 12 weeks

  6. Modified Push Up Test

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

    Measured: At baseline and at the end of 12 weeks

  7. Curl Up Test

    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.

    Measured: At baseline and at the end of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start1 Jun 2022
  3. Primary completion15 Feb 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629883
Sponsor's protocol ID
Pro00120540
Acronym
REPS w/BANDS
Status last verified
Oct 2024
First submitted
2 Oct 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD was not shared to maintain participant confidentiality. Participants were assigned a unique identifier. All data was secured on university research servers that have multiple fire walls and are password protected. Source documents are stored in locked filing cabinets in a locked office in the College of Nursing. Source data have the participant identifier only. Findings will be reported in aggregate form.

Publications

  • 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.

    PubMed 34567361

  • 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.

    PubMed 30123008

  • 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.

    PubMed 24151290

  • 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/

  • Wright PJ, Corbett CF. Resistance Exercise and Peer Support with Bands/Balls and Digitally-based Supervision: (REPS w/BANDS): a feasibility study for women with PCOS. Pilot Feasibility Stud. 2026 Jul 20. doi: 10.1186/s40814-026-01887-7. Online ahead of print.

    PubMed 42477852

Questions about this trial

What is this clinical trial studying?

A study testing REPS w/BANDS in people with Polycystic Ovary Syndrome (PCOS), run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: At the end of 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629883, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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