Clinical trial NCT04090476: BIG for Life: a Pilot Study
Official title: Impact of a High Intensity Community Exercise Group (BIG for Life) on Motor Function (i.e. Balance, Gait, Strength, Balance Confidence), Ability to Perform Activities of Daily Living, and Quality of Life Measures in Individuals With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: community exercise group
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study will aim to evaluate BIG for LIFE as a group exercise program, and determine whether three time a week exercise sessions with heart rate monitoring is beneficial to maintain or improve physical function, cognitive function, and quality of life over a period of 8 weeks (pre/post testing and 24 visits).

The specific objective of this study is to investigate the impact of this exercise group (BIG for LIFE) on motor functions (i.e. balance, gait, strength, balance confidence) and quality of life functions (sleep, depression, activities of daily living)

The investigators will test the following hypotheses:

1. that participation in this community-based exercise group will improve mobility level and balance confidence
2. that participation in this group will increase performance of activities of daily living as measured by self-assessment
3. that participation in this group will increase quality of life, cognition, sleep, or depression measures
4. that providing real time heart rate feedback in this group setting will increase the amount of time spent exercising in the target heart rate zone

Detailed description: Study participants will complete a total of 24 exercise sessions (in person or via Zoom). At the initial session, participants will undergo screening and consent, physical assessments (10 meter walk test, 6 minute walk test, 5 Times Sit to Stand, and the Mini Bestest) and routine baseline medical assessments (Appearance, Pulses, BP) and complete self-assessments regarding balance (Activities Balance Confidence Questionnaire, ABC) and cognitive assessment with Trails A/B, quality of life (PDQ-39,PHQ-9, PDSS-2, FOG-q, and Patient-Specific Functional Scale); these assessments will be repeated at the final visit. In person assessments preferred but if unable due to health regulations they can be administered virtually. For virtual assessments the miniBESTest and 6 minute walk test will not be administered, all others can be administered virtually. Questionnaires will be mailed as well as instructions/materials for physical assessments for virtual assessments. Physical assessments will occur via zoom with help from family member or other individual. Participants will be also instructed in use of the heart rate monitor and will be instructed in importance of exercising at a moderate intensity.

During each of the exercise sessions the LSVT Big daily exercises will be performed along with functional tasks and gait/balance tasks. The functional tasks and gait/balance tasks will change weekly to monthly and all activities will be modified to the participant's mobility level. We will compare changes in assessment and questionnaire scores before and after completion of the 8-week (24 exercise sessions) intervention, anticipating that participants will either improve or not experience significant degradation of cognitive, physical or motor function, as can be observed in PD patients after completion of the exercise program.

Upon completion of the 8-week exercise program, assessments and questionnaires will be repeated, and the participants will be interviewed to gain anecdotal insight into their experience with the program. Using the rolling enrollment strategy, we will be able to accumulate data to provide interim insight into the progress on our study objectives, and to assess whether the number of subjects estimated is appropriate to achieve statistical power to support or reject our hypotheses.

Eligibility criteria: Inclusion Criteria:

* People with Parkinson's disease age 18 or over, male or female will be included.

Exclusion Criteria:

* Persons under the age of 18 and those without a diagnosis of Parkinson's disease will be excluded from the study. Individuals with PD who are bed bound or wheelchair bound will be excluded. Scores of \<23 on the MOCA will be excluded due to risk of cognitive impairments which may limit participation and ability to consent. Participants must be cleared for participation in the community exercise program by their physician.

Primary outcomes:
measure: Change in Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Parkinson's Disease Sleep Scale - Version 2 (PDSS-2)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Freezing of Gait Questionairre (FOG-q)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in 5 times sit to stand
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in 3M Backwards Walk Test
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in 10 meter walk test
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in 6 minute walk test
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Mini-BESTest
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
measure: Change in Patient Specific Functional Scale (PSFS)
timeFrame: Baseline and 8 weeks later (after 24 recorded exercise sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United States
facility: Rock Steady Boxing Gym
state: New York
Study officials:
References:
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citation: Bloem BR, Marinus J, Almeida Q, Dibble L, Nieuwboer A, Post B, Ruzicka E, Goetz C, Stebbins G, Martinez-Martin P, Schrag A; Movement Disorders Society Rating Scales Committee. Measurement instruments to assess posture, gait, and balance in Parkinson's disease: Critique and recommendations. Mov Disord. 2016 Sep;31(9):1342-55. doi: 10.1002/mds.26572. Epub 2016 Mar 4.
citation: Martinez-Martin P, Jeukens-Visser M, Lyons KE, Rodriguez-Blazquez C, Selai C, Siderowf A, Welsh M, Poewe W, Rascol O, Sampaio C, Stebbins GT, Goetz CG, Schrag A. Health-related quality-of-life scales in Parkinson's disease: critique and recommendations. Mov Disord. 2011 Nov;26(13):2371-80. doi: 10.1002/mds.23834. Epub 2011 Jul 6.
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