BIG for Life: a Pilot Study

NCT04090476 | Completed

• 1 other identifier: 1441170
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.that participation in this community-based exercise group will improve mobility level and balance confidence
2. 2.that participation in this group will increase performance of activities of daily living as measured by self-assessment
3. 3.that participation in this group will increase quality of life, cognition, sleep, or depression measures
4. 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

Conditions

Parkinson Disease

Keywords

community exercise group

Outcome Measures

Primary Outcomes (11)

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

  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.

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

• Change in Patient Health Questionnaire (PHQ-9)

  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.

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

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

  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.

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

• Change in Freezing of Gait Questionairre (FOG-q)

  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.

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

• Change in Activities-Specific Balance Confidence Scale (ABC)

  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.

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

• Change in 5 times sit to stand

  Lower extremity strength measure

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

• Change in 3M Backwards Walk Test

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

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

• Change in 10 meter walk test

  Gait speed measure

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

• Change in 6 minute walk test

  Walking Endurance Measure

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

• Change in Mini-BESTest

  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.

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

• Change in Patient Specific Functional Scale (PSFS)

  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.

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

Study Arms (1)

BIG for Life Exercise Group

EXPERIMENTAL

This arm includes the entire cohort enrolled who will participate in the three times a week one hour community exercise group for a total of 8 weeks

Other: Exercise

Interventions

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.

BIG for Life Exercise Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

Rock Steady Boxing Gym

Liverpool, New York, 13088, United States

Location

Related Publications (7)

• McDonnell MN, Rischbieth B, Schammer TT, Seaforth C, Shaw AJ, Phillips AC. Lee Silverman Voice Treatment (LSVT)-BIG to improve motor function in people with Parkinson's disease: a systematic review and meta-analysis. Clin Rehabil. 2018 May;32(5):607-618. doi: 10.1177/0269215517734385. Epub 2017 Oct 5.

  PMID: 28980476 BACKGROUND

• Janssens J, Malfroid K, Nyffeler T, Bohlhalter S, Vanbellingen T. Application of LSVT BIG intervention to address gait, balance, bed mobility, and dexterity in people with Parkinson disease: a case series. Phys Ther. 2014 Jul;94(7):1014-23. doi: 10.2522/ptj.20130232. Epub 2014 Feb 20.

  PMID: 24557655 BACKGROUND

• Ebersbach G, Ebersbach A, Edler D, Kaufhold O, Kusch M, Kupsch A, Wissel J. Comparing exercise in Parkinson's disease--the Berlin LSVT(R)BIG study. Mov Disord. 2010 Sep 15;25(12):1902-8. doi: 10.1002/mds.23212.

  PMID: 20669294 BACKGROUND

• Phannarus H, Muangpaisan W, Siritipakorn P, Chotinaiwattarakul W. Cognitive profiles and optimal cut-offs for routine cognitive tests in elderly individuals with Parkinson's disease, Parkinson's disease dementia, Alzheimer's disease, and normal cognition. Psychogeriatrics. 2020 Jan;20(1):20-27. doi: 10.1111/psyg.12451. Epub 2019 Mar 25.

  PMID: 30912230 BACKGROUND

• 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.

  PMID: 26945525 BACKGROUND

• 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.

  PMID: 21735480 BACKGROUND

• Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.

  PMID: 21312275 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: May 10, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)