BIG for Life: a Pilot Study
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: community exercise group