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Completed

NCT Number: NCT04090476

BIG for Life: a Pilot Study

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rock Steady Boxing Gym

Liverpool, New York, 13088, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. Change in Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    The PDQ-39 is a 39 item self-report questionnaire which assesses Parkinson's disease specific health related quality over the last month across 8 quality of life dimensions (activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, social support). Items are answered on a 5 point ordinal scale (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always) Lower scores reflect better quality of life. The sum of scores is divided by the maximum score and multiplied by 100.

  2. Change in Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scores are added and divided by 27. Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

  3. Change in Parkinson's Disease Sleep Scale - Version 2 (PDSS-2)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    The PDSS-2 is a 15 item self-report questionnaire specific to sleep quality for individuals with Parkinson's disease. It uses a 5 point scale (04=very often, 3=often, 2=sometimes, 1=occasionally, 0=never) Score ratings are added and lower scores correlate with better sleep quality.

  4. Change in Freezing of Gait Questionairre (FOG-q)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    FOG-Q is a 16 item self-report measure used to asses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease. There are 6 items (4 items assess FOG severity and 2 items assess gait). Responses use a a 5-point ordinal scale from 0 (absence) to 4 (most severe). Total scores range from 0 to 24 with higher scores indicating more severe FOG.

  5. Change in Activities-Specific Balance Confidence Scale (ABC)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    The Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence) A higher score indicates more balance confidence.

  6. Change in 5 times sit to stand

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    Lower extremity strength measure

  7. Change in 3M Backwards Walk Test

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    Timed measure of Backwards Walk over the distance of 3M.

  8. Change in 10 meter walk test

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    Gait speed measure

  9. Change in 6 minute walk test

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    Walking Endurance Measure

  10. Change in Mini-BESTest

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    The Mini-BESTest is a measure of dynamic balance, functional mobility, and gait. It consists of 14 items under the sections of anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. It is scored out of 28 points with a 3-level ordinal scale (0-2) with higher scores indicating better balance.

  11. Change in Patient Specific Functional Scale (PSFS)

    Time frame: Baseline and 8 weeks later (after 24 recorded exercise sessions)

    This is a questionnaire to quantify activity limitation and measure functional outcomes. Participants choose up to 7 functional activities to rate on an 11 point ordinal scale from 0=unable to perform activity to 10= able to perform at the same level as before the problem. Total score=sum of the activity scores/number of activities.

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2019
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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