Support + High Intensity Functional Training for Parkinson's

Parkinson Disease Clinical Trial

— SHIFT-PD  

Official title:

Support + High Intensity Functional Training for Parkinson's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225506
• Other study ID #: PT-2021-025
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: November 24, 2022

Study information

• Verified date: July 2023
• Source: Arkansas Colleges of Health Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's is the fastest growing neurological disorder in the world. With more people living with Parkinson's than ever before, there is an urgent need for interventions that improve health and reduce disability. High intensity exercise has shown to be superior to other forms of exercise in that it can slow symptom progression. High intensity exercise also reduces the risk of cardiovascular events. This is pertinent considering one in five people with Parkinson's will die from cardiovascular disease. While Parkinson's specific exercise programs across the U.S. continue to increase, there are still many communities with limited to no access, including Fort Smith, Arkansas. Here, there are no expert level centers within 100 miles and not a single community-based exercise program. This research will offer a community and group-based exercise program for participants with Parkinson's and their care partners.

Description:

This study, Support + High Intensity Functional Training for Parkinson's (SHIFT-PD), will provide no-cost, twice weekly, group-based, adaptable exercise programming for people with Parkinson's and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise (please see attached medical release form). All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study (please see methodology section below). All eligible participants will complete a demographics questionnaire requesting participant age, sex, race/ethnicity, marital status, household income, primary means of locomotion, month and/or year of Parkinson's diagnosis (people with Parkinson's only), relationship to participant with Parkinson's (care partner only). Demographic data will be utilized to describe the study population participating in the research study and to evaluate barriers and facilitators for participation. All eligible participants will undergo a battery of baseline outcome assessments prior to undergoing the exercise intervention.

Participants will participate in a maximum of twice weekly group-based exercise classes for up to 6 months. All exercise programming will be led by licensed physical therapists at a local gym, CrossFit Fort Smith. All physical therapists will be CPR/BLS certified and an automated external defibrillator will be available onsite. Exercise classes will incorporate aerobic, resistance, and/or balance training. Exercise intensity will be monitored by participant vital signs and/or participant Rating of Perceived Exertion. SHIFT-PD will follow all state, federal, and CDC guidelines regarding COVID-19 precautions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for people with Parkinson's

• Participants must be at least 18 years of age

• Participants must have a diagnosis of Parkinson's disease

• Participants must be able to communicate and read in English

• Participants must have physician or advanced practice provider clearance to exercise

• Participants must provide their own transportation to and from the research study

• Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently

Inclusion criteria for people who identify as care partners of those with Parkinson's

• Participants must be at least 18 years of age

• Participants must be able to communicate and read in English

• Participants must have physician or advanced practice provider clearance to exercise

• Participants must be a self-identified care partner of a person with Parkinson's participating in the study

• Participants must provide their own transportation to and from the research study

• Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently

Exclusion Criteria:

-Failure to meet above listed inclusion criteria

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Exercise
Exercise sessions will be one hour in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on movements specifically targeting common deficits seen in Parkinson's.

Locations

Country	Name	City	State
United States	Arkansas Colleges of Health Education	Fort Smith	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Colleges of Health Education

Country where clinical trial is conducted

United States, 

References & Publications (6)

Benka Wallen M, Franzen E, Nero H, Hagstromer M. Levels and Patterns of Physical Activity and Sedentary Behavior in Elderly People With Mild to Moderate Parkinson Disease. Phys Ther. 2015 Aug;95(8):1135-41. doi: 10.2522/ptj.20140374. Epub 2015 Feb 5. — View Citation

Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3. — View Citation

Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131. — View Citation

Pennington S, Snell K, Lee M, Walker R. The cause of death in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2010 Aug;16(7):434-7. doi: 10.1016/j.parkreldis.2010.04.010. Epub 2010 May 31. — View Citation

Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517. — View Citation

Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Attendance at 6 months	The percentage of interventions sessions attended by participants.	After 6 months of exercise intervention
Secondary	Change in lower extremity functional strength at 6 months	Lower extremity strength will be measured via functional test (Five Times Sit to Stand). This test records the amount of time taken to rise and sit to and from a chair five consecutive times. Faster times indicate greater lower extremity strength.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in grip strength at 6 months	Grip strength will be measured via hand held dynamometry. Participants will perform three trials using their dominant hand. The force of each grip will be recorded and averaged in pounds.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Activities Specific Balance Confidence (ABC) Scale at 6 months	The ABC scale is a 16-item participant-reported measure of balance confidence while performing various activities. Participants rank their level of confidence from 0 (not at all confident) to 100 (completely confident); scores from each item are then averaged for one final score. The maximum score is 100%, indicating high balance confidence.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 6 months	The PDQ-39 is a 39-item participant-reported questionnaire which assesses health-related quality of life across 8 domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Participants respond to each item using a 5-point Likert scale from 0 (never) to 4 (always). Items in each domain are scored by expressing summed item scores as a percentage (ranging from 0 to 100%). Lower scores indicate better quality of life.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Mini Balance Evaluation Systems Test (Mini BESTest) at 6 months	The Mini BESTest is a 14-item test that assesses Anticipatory balance, reactive postural control, sensory orientation and dynamic gait. Performance for each item is ranked on a 3-point ordinal scale (0,1, or 2) with a total possible score of 28 (indicating good balance).	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in fast-paced gait speed at 6 months	Fast-paced walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in casual gait speed at 6 months	Walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Social Support for Exercise Scale at 6 months	The Social Support for Exercise Scale contains 13 items and asks participants to rank frequency of supporting exercise behaviors amongst both family and friends on a 5-point Likert scale (1, none to 5, very often). Scores range from 13 to 65 with higher scores indicating greater social support for exercise.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Self efficacy for exercise scale at 6 months	The Self-Efficacy for Exercise Scale contains 9 items and asks participants to rank their confidence (0, not confident to 10, very confident) in their ability to exercise three times per week for 20 minutes in 9 different scenarios. Scores range from 0 to 90 with higher scores indicating greater exercise self-efficacy.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in 6 Minute Walk Test at 6 months	The 6 Minute Walk Test measures a participants ability to cover as much distance (measured in meters) as possible while walking for 6 minutes. Participants will walk along a pre-defined pathway for 6 minutes, resting as needed. The test is a measure of walking endurance with further distances indicating greater endurance.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Rand 36-Item Health Survey at 6 months	Health related quality of life will be measured via Rand 36-item Health Survey. This 36 item survey asks participants about their health in several categories (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health). Scores in each category are averaged and range from 0 to 100, with higher scores indicating better health-related quality of life.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 6 months	The MDS-UPDRS measures disability as a result of Parkinson's and allows tracking for progression of the disease. The scale has four parts (1, mentation, behavior and mood, 2, activities of daily living, 3, motor examination, and 4, complications of therapy. Each parkinsonian sign or symptom is ranked on a 5-point Likert scale (ranging from 0 to 4) with higher scores indicating greater impairments. The minimum score on the entire scale is 0 and the maximum is 199.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in Global Rating of Change at 6 Months	Participants will rate their perceived level of change on a 15-point Likert Scale ranging from -7 (a very great deal less/worse to +7 (a very great deal more/better) with 0 representing no change. They will use this scale to answer 6 separate questions: 1) amount of physical activity performed in an average week, 2) ability to walk leisurely, 3) ability to walk fast, 4) ability to walk for a long period of time, 5) ability to stand up from a seated position, 6) ability to steady yourself and prevent a fall.	After 6 months of exercise intervention (T3)
Secondary	Change in Self-Reported Physical Activity Level at 6 Months	Participants report their perceived physical activity levels compared to people their own age using a 5-point Likert Scale ranging from "much more active" to "much less active".	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Change in accelerometer-measured moderate-to-vigorous physical activity at 6 months	Physical activity levels will be measured via thigh-worn accelerometer (activPAL). This small device will be worn on the less affected thigh (or right thigh for care partners) of participants with Parkinson's. The activPAL is able to detect acceleration and body position (i.e. sitting, standing, or lying). Through collecting acceleration data, different intensities of physical activity will be inferred (i.e light, moderate and vigorous intensity physical activity), with moderate-to-vigorous intensity physical activity being used as the primary outcome measure. At all time points, participants will wear the activPAL for 7 consecutive days. The activPAL will be waterproofed and will not need to be removed for activities such as bathing.	Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
Secondary	Participant Retention	The number and percentage of participants who remain in the study through the final measurement point at 6 months.	After 6 months of exercise intervention (T3)
Secondary	Participant Recruitment Rate	The number of participants recruited will be reported as a percentage of total participants contacted for study participation.	Throughout the 6-month study period