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

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome (PCOS)
Interventions
Behavioral: REPS w/BANDS
Registration Number
NCT06629883
Lead Sponsor
University of South Carolina
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
10
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
REPS w/BANDSREPS w/BANDSThe 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.
Primary Outcome Measures
NameTimeMethod
RecruitmentAt the end of 12 weeks

Screened participants # / Enrolled participants #

RetentionAt the end of 12 weeks

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

Acceptability InterviewsAt the end of 12 weeks

Acceptability was measured via content analysis of participant interviews

Acceptability Likert ScalesAt 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.

AttendanceAt the end of 12 weeks

Session # attended / Session # prescribed

Secondary Outcome Measures
NameTimeMethod
Depressive SymptomsFrom 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

BodyweightAt baseline and at the end of 12 weeks

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

HeightAt baseline and at the end of 12 weeks

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

Waist CircumferenceAt baseline and at the end of 12 weeks

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

Squat TestAt 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.

Modified Push Up TestAt 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.

Curl Up TestAt 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.

Trial Locations

Locations (1)

Clinical Exercise Research Center

🇺🇸

Columbia, South Carolina, United States

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