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临床试验/NCT05772884
NCT05772884已完成不适用

The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment

University of Florida2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Intervention adherence

研究概览

简要总结

This study aims to examine the effectiveness of a supervised aerobic exercise program for persons with Opioid Use Disorder (OUD). Participants will be enrolled in a 12-week supervised aerobic exercise intervention.

详细描述

The overall project goals are to test the feasibility and acceptability of our aerobic exercise intervention with this population. Study participation will include a screening and enrollment phase, a baseline assessment, and a 12-week intervention. Participants will be recruited and consented by University of Florida (UF) study staff.

研究设计

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

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults must be aged 21-64 years old
  • Currently enrolled in OMT (opioid maintenance treatment) or present with at least mild opioid use disorder (endorses at least 2 DSM-V criteria for OUD within a 12-month period),
  • Insufficiently physically active (defined as exercising < 20 minutes 3 times/week
  • Able to understand and speak English
  • Have a body mass index 18.5-40 kg/m^2
  • Willing and able to visit research center up to one time time/week for 12 weeks
  • Participants will undergo a supervised maximal exercise test and physical exam by medical supervisor to be cleared for participation.

排除标准

  • Participants must not have heart disease, or had a stroke, uncontrolled diabetes, thyroid condition an eating disorder
  • An uncontrolled major psychiatric condition (e.g., schizophrenia; conditions that are well-controlled, however [e.g., anxiety controlled through therapy] will not be exclusionary), or other medical condition(s) that contraindicate exercise; and may not be participating in a structured exercise training or weight loss program.
  • Participants cannot be pregnant; pregnancy is exclusionary
  • One individual per household may enroll.

结局指标

主要结局

Intervention adherence

时间窗: Up to 13 weeks

Measured as percent study sessions completed on-time (+/- 1 hour of the scheduled session) and the proportion of participants who achieved \>75% adherence.

Recruitment feasibility

时间窗: Baseline up to 4 weeks

Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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