Clinical trial NCT06170866: Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.
Official title: Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Peer Support
Hispanic
Parkinson´s Disease
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2023-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective feasibility trial, single group pre-posttest design and it aims to enroll 20 participants. For this feasibility study, the sample size is comparable to other feasibility trials in populations of individuals with Parkinson disease (Lima \& Rodrigues-de-Paula, 2013; Ellis et al., 2013, Colón-Semenza et al., 2018)17,19,20. This sample size will allow for a comparison in feasibility, acceptability, and appropriateness within and across groups. This sample will allow for identifying trends and preliminary efficacy for this intervention. This study will help to inform an appropriate sample size to adequately power larger samples in future studies
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease.

The main question\[s\] it aims to answer are:

* What is the feasibility of the peer partner training program?
* What is the feasibility of the peer-supported mobile health physical activity intervention?
* What are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy?

Participants will be asked to:

* Wear a research-grade activity monitor, Actigraph GT9X device for 10 days at the beginning and end of the study.
* Watch 11 educational videos about Parkinson´s disease and exercise and attend two virtual educational sessions.
* Connect with another person with Parkinson´s disease one time a week on a virtual meeting platform for 8 weeks.
* Use Fitbit activity monitors and connect with other participants through the Fitbit application for 8 weeks.
* Attend a weekly online exercise class for 8 weeks with other people with Parkinon´s disease.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson disease,
* Able to walk without the assistance of another person for 10 minutes

  -≥ 29 on Telephone Interview for Cognitive Status (TICS)
* To have a close friend/family member over the age of 18 that would support the participant during the intervention

  -≥ 50 years of age
* Hispanic
* To be willing to use an activity monitor and use a Fitbit and Fitbit application
* To be on a stable course of PD medications without any plans for change over the next 3 months
* To be able to speak, read and write in Spanish or English

Exclusion Criteria:

* Unstable cardiopulmonary, orthopedic, psychological or metabolic condition
* Atypical Parkinsonism Disorders
* A fall in the last 6 months (that was unrelated to an external force)
* Currently engaging in 150 minutes of mod-vigorous physical activity/week

Primary outcomes:
measure: Feasibility of Peer Training as measured by Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)
timeFrame: After completion of peer training (2 to 3 weeks) and after completion of the intervention (8 weeks)
measure: Feasibility of Peer Support for physical activity
timeFrame: After completion of peer training (2 to 3 weeks) and after completion of the intervention (8 weeks)
Secondary outcomes:
measure: Objective measurement of physical activity
timeFrame: 10 days at baseline and post-intervention (approximately 12 to 14 weeks)
measure: Motivation of physical activity measurement
timeFrame: Baseline and post Intervention (approximately 12 to 14 weeks)
measure: Quality of Life Measurement
timeFrame: Pre and post intervention (approximately 12 to 14 weeks)
measure: Depression and Apathy Screening
timeFrame: Pre and post intervention (approximately 12 to 14 weeks)
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Cristina Colón-Semenza, PhD
role: PRINCIPAL_INVESTIGATOR
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