Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.
NCT ID: NCT06170866
Last Updated: 2025-11-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-01
Study Completion Date
2024-08-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Parkinson Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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 Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Social support for physical activity
Socially supported (peer, family and group) physical activity group.
Group Type
EXPERIMENTAL
Socially supported physical activity
Intervention Type
BEHAVIORAL
Use of a culturally and linguistically tailored intervention that uses mobile health technology plus social support to increase engagement in physical activity in the management of Parkinson´s disease.
Interventions
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Socially supported physical activity
Use of a culturally and linguistically tailored intervention that uses mobile health technology plus social support to increase engagement in physical activity in the management of Parkinson´s disease.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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UConn Health
OTHER
Sponsor Role
lead
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Responsible Party
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Cristina Colón-Semenza
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cristina Colón-Semenza, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Connecticut
Locations
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University of Connecticut
Storrs, Connecticut, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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23-117S-2
Identifier Type: -
Identifier Source: org_study_id
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