跳至主要内容
临床试验/NCT06605183
NCT06605183招募中不适用

10,000 STEP CLUB: Community Walking Program to Decrease Sedentary Behavior, Fear of Falling Avoidance Behavior, Loneliness, and Social Isolation in Parkinson's Disease

University of Nevada, Las Vegas2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Daily step count average

研究概览

简要总结

The 10,000 Step Club (10KSTC) is a 6-month community walking program for people with Parkinson's disease (PwP) and their caregivers in Las Vegas, Nevada (LV). This program will consist of several weekly, organized walking groups in local parks throughout the LV Valley. Participants in the program will use Nordic walking poles during the walks. Each walking group will meet once per week at a local park and will be supervised by walking group leaders from the University of Nevada, Las Vegas. There will be three walking programs throughout the Las Vegas valley. Participants will be given a step watch to wear step counts will be tracked in real-time. The program is designed to get PwP out of their homes, cultivate a culture of connection with others with Parkinson's disease (PD), and to be collectively accountable for a common goal toward 10,000 steps per day.

详细描述

The 10,000 Step Club (10KSC) is a 6-month community walking program conducted at various local parks in Las Vegas (LV), Nevada for people with Parkinson's disease (PD). There will be three walking groups and each group will meet at a local park once weekly for a 60-minute walk. These walking groups will be led by UNLV physical therapy students who will organize, coordinate, and manage the different walking groups. Participants will be encouraged to attend at least one walking group per week in their area but will be permitted to participate at the other walking groups on different days if they desire to get in a second or third walk that week. Participants in the program will use Nordic walking poles to promote stability and upright posture, and to encourage full body movement and arm use.

There will be three different walking groups throughout Las Vegas in areas with few PD exercise programs and higher proportions of people with Parkinson's disease in lower socioeconomic regions and historically underserved areas. The 10KSC program will be offered in both English and Spanish. Participants will be given a step watch to wear over the 6 months of the program and will be encouraged to build up their physical activity to eventually average 10,000 steps per day. The watches will be used to track step counts in real-time and there will be an incentive program to motivate participants and recognize achievements related to program goals. The program is designed to get people with Parkinson's disease out of their homes, cultivate a culture of connection with others with Parkinson's disease to decrease social isolation and loneliness, and to be collectively accountable for a common goal toward more physical activity. The 10KSC will be evaluated for effectiveness, feasibility, and safety. The program will target recruitment of 60 participants with Parkinson's disease. Participation will be free of charge and care partners will be encouraged to participate as well. The program inclusion criteria will be "pragmatic" which means that there will be few exclusion criteria and the only inclusion criterion will be a diagnosis of Parkinson's disease by a neurologist.

研究设计

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

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30-85 years old
  • Neurologist-diagnosed Parkinson's disease
  • Able to walk independently with or without a walking aid (e.g., cane, walker)
  • Willing to participate in a 6-month study

排除标准

  • Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
  • Dementia. This will be determined by completing the Montreal Cognitive Assessment
  • Participants with poor walking ability (determined using the Timed Up and Go Test during initial testing).

结局指标

主要结局

Daily step count average

时间窗: From enrollment to the end of the 6-month community walking program.

Daily step count average over one week as determined using a step watch and using real-time data acquisition software.

Fear of Falling Avoidance Behavior

时间窗: From enrollment to the end of the 6-month community walking program.

This will be assessed using the modified Fear of Falling Avoidance Behavior Questionnaire which is a self-report scale ranging from 0 to 56 with higher scores suggestive of more fear of falling avoidance behavior.

Social isolation

时间窗: From enrollment to the end of the 6-month community walking program.

Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 - Social Isolation - Short Form 8a. This is a self-report questionnaire ranging from 8 to 40 with higher scores suggestive of more social isolation.

Loneliness

时间窗: From enrollment to the end of the 6-month community walking program.

Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 - Loneliness - Fixed Form. This is a self-report questionnaire with scores ranging from 5 to 25 with higher scores suggestive of more loneliness.

Self-efficacy

时间窗: From enrollment to the end of the 6-month community walking program.

Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 - Self-Efficacy for Chronic Conditions - Managing Emotions - Short Form 8a. This is a self-report questionnaire with scores ranging from 8 to 40 with higher scores suggestive of more self-efficacy.

次要结局

  • Program goals - feasibility(Through the completion of the study, an average of 6-months.)
  • Program goals - safety(Through the completion of the study, an average of 6-months.)
  • Enrollment goals - diversity(Through the completion of the study, an average of 6-months.)

研究者

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

Merrill Landers

Primary investigator

University of Nevada, Las Vegas

研究点 (2)

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