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临床试验/NCT06629883
NCT06629883已完成不适用

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

University of South Carolina1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Attendance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

REPS w/BANDS

Experimental

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.

干预措施: REPS w/BANDS (Behavioral)

结局指标

主要结局

Attendance

时间窗: At the end of 12 weeks

Session # attended / Session # prescribed

Recruitment

时间窗: At the end of 12 weeks

Screened participants # / Enrolled participants #

Retention

时间窗: At the end of 12 weeks

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

Acceptability Interviews

时间窗: At the end of 12 weeks

Acceptability was measured via content analysis of participant interviews

Acceptability Likert Scales

时间窗: 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.

次要结局

  • Curl Up Test(At baseline and at the end of 12 weeks)
  • Depressive Symptoms(From baseline and at the end of 12 weeks)
  • Bodyweight(At baseline and at the end of 12 weeks)
  • Height(At baseline and at the end of 12 weeks)
  • Waist Circumference(At baseline and at the end of 12 weeks)
  • Squat Test(At baseline and at the end of 12 weeks)
  • Modified Push Up Test(At baseline and at the end of 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela J. Wright

Assistant Professor

University of South Carolina

研究点 (1)

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