NCT06170866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

November 10, 2023

Results QC Date

September 22, 2025

Last Update Submit

November 12, 2025

Conditions

Keywords

ExercisePeer SupportHispanicParkinson´s Disease

Outcome Measures

Primary Outcomes (3)

  • Acceptability of Intervention Measure (AIM)

    A standardized measure of acceptability that indicates percent agreement with acceptability of the intervention ranging from 20-100%. Higher scores indicate agreement (better outcome) with the acceptability of the intervention.

    After completion of the entire intervention (11 weeks)

  • Intervention Appropriateness Measure (IAM)

    A standardized measure of appropriateness that indicates percent agreement with appropriateness of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the appropriateness of the intervention.

    After completion of the entire intervention (11 weeks)

  • Feasibility of Intervention Measure (FIM)

    A standardized measure of feasibility that indicates percent agreement with feasibility of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the feasibility of the intervention.

    After completion of the entire intervention (11 weeks)

Secondary Outcomes (4)

  • Objective Measurement of Physical Activity

    10 days at baseline and post-intervention (approximately 12 to 14 weeks)

  • Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)

    Baseline and post Intervention (approximately 12 to 14 weeks)

  • Parkinson's Disease Questionnaire-39 (PDQ-39)

    Pre and post intervention (approximately 12 to 14 weeks)

  • Geriatric Depression Scale-Short Form

    Pre and post intervention (approximately 12 to 14 weeks)

Study Arms (1)

Social support for physical activity

EXPERIMENTAL

Socially supported (peer, family and group) physical activity group.

Behavioral: Socially supported physical activity

Interventions

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.

Social support for physical activity

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Results Point of Contact

Title
Dr. Cristina Colon-Semenza, Assistant Professor
Organization
University of Connecticut

Study Officials

  • Cristina Colón-Semenza, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2023

First Posted

December 14, 2023

Study Start

June 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 30, 2024

Last Updated

November 26, 2025

Results First Posted

November 26, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations