Parkinson Disease
Conditions
Keywords
Exercise, Peer Support, Hispanic, Parkinson´s Disease
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.
Interventions
BEHAVIORALSocially 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
UConn Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | After completion of the entire intervention (11 weeks) | 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. |
| Intervention Appropriateness Measure (IAM) | After completion of the entire intervention (11 weeks) | 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. |
| Feasibility of Intervention Measure (FIM) | After completion of the entire intervention (11 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Measurement of Physical Activity | 10 days at baseline and post-intervention (approximately 12 to 14 weeks) | Steps per day measured using a research-grade activity monitor will provide group mean change in physical activity from baseline to post-intervention. |
| Geriatric Depression Scale-Short Form | Pre and post intervention (approximately 12 to 14 weeks) | The Geriatric Depression Scale (GDS) -15, is a 15-item self-report measure of depression in older adults. The score ranges from 0-15 with higher scores indicating higher levels of depression (worse outcome). Group mean change scores related to depression are reported. |
| Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) | Baseline and post Intervention (approximately 12 to 14 weeks) | The Behavioral Regulation in Exercise Questionnaire-2, Relative Autonomy Index, is a standardized, 19-item survey that evaluates motivation for exercise. The scores range from -24 to +20 with higher scores indicating increased motivation or better outcomes. The group mean change score is presented. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | Pre and post intervention (approximately 12 to 14 weeks) | The Parkinson's Disease Questionnaire-39 (PDQ-39) is a 39-item, self-report survey that assess quality of life. The scores range from 0-100 and a decrease indicates an improvement in quality of life. The group mean change total scores will be evaluated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Social Support for Physical Activity Socially supported (peer, family and group) physical activity group. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Social Support for Physical Activity |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8 |
| Disease duration | 8.2 years STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: After completion of the entire intervention (11 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Acceptability of Intervention Measure (AIM) | 93 score on a scale | Standard Deviation 8.56 |
Primary
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.
Time frame: After completion of the entire intervention (11 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Feasibility of Intervention Measure (FIM) | 87 score on a scale | Standard Deviation 11.11 |
Primary
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.
Time frame: After completion of the entire intervention (11 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Intervention Appropriateness Measure (IAM) | 89 score on a scale | Standard Deviation 10.21 |
Secondary
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
The Behavioral Regulation in Exercise Questionnaire-2, Relative Autonomy Index, is a standardized, 19-item survey that evaluates motivation for exercise. The scores range from -24 to +20 with higher scores indicating increased motivation or better outcomes. The group mean change score is presented.
Time frame: Baseline and post Intervention (approximately 12 to 14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) | 0.55 score on a scale | Standard Deviation 1.96 |
Secondary
Geriatric Depression Scale-Short Form
The Geriatric Depression Scale (GDS) -15, is a 15-item self-report measure of depression in older adults. The score ranges from 0-15 with higher scores indicating higher levels of depression (worse outcome). Group mean change scores related to depression are reported.
Time frame: Pre and post intervention (approximately 12 to 14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Geriatric Depression Scale-Short Form | -1.15 score on a scale | Standard Deviation 2.17 |
Secondary
Objective Measurement of Physical Activity
Steps per day measured using a research-grade activity monitor will provide group mean change in physical activity from baseline to post-intervention.
Time frame: 10 days at baseline and post-intervention (approximately 12 to 14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Objective Measurement of Physical Activity | 110.77 steps/day | Standard Deviation 1891.27 |
Secondary
Parkinson's Disease Questionnaire-39 (PDQ-39)
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a 39-item, self-report survey that assess quality of life. The scores range from 0-100 and a decrease indicates an improvement in quality of life. The group mean change total scores will be evaluated.
Time frame: Pre and post intervention (approximately 12 to 14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social support for physical activity | Parkinson's Disease Questionnaire-39 (PDQ-39) | -7.11 score on a scale | Standard Deviation 8.98 |