Resistance Exercise and Peer Support with Bands/balls and Digital Support Among Women with Polycystic Ovary Syndrome (REPS w/BANDS)

October 3, 2024 updated by: Pamela J. Wright, University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Clinical Exercise Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: At the end of 12 weeks
Screened participants # / Enrolled participants #
At the end of 12 weeks
Attendance
Time Frame: At the end of 12 weeks
Session # attended / Session # prescribed
At the end of 12 weeks
Retention
Time Frame: At the end of 12 weeks
Participant # completing 2nd assessment / Participant # completing baseline assessment
At the end of 12 weeks
Acceptability Interviews
Time Frame: At the end of 12 weeks
Acceptability was measured via content analysis of participant interviews
At the end of 12 weeks
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.
At the end of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline and at the end of 12 weeks
Bodyweight
Time Frame: At baseline and at the end of 12 weeks
Participants self-reported body weight in pounds during the fitness assessments.
At baseline and at the end of 12 weeks
Height
Time Frame: At baseline and at the end of 12 weeks
Participants self-reported height in feet and inches during the fitness assessments.
At baseline and at the end of 12 weeks
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.
At baseline and at the end of 12 weeks
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.
At baseline and at the end of 12 weeks
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.
At baseline and at the end of 12 weeks
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.
At baseline and at the end of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Investigators

  • Principal Investigator: Pamela J Wright, PhD, MS, MEd, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00120540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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