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The Purpose of This Pilot Study is to Investigate the Impact of a Weekly 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.

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ClinicalTrials.gov Identifier: NCT04090476
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Amy DeBlois, State University of New York - Upstate Medical University

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 16, 2019
Estimated Study Start Date  ICMJE September 13, 2019
Estimated Primary Completion Date September 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • PDQ-39 [ Time Frame: 8 weeks ]
    Quality of Life Measure for PD
  • PHQ-9 [ Time Frame: 8 weeks ]
    Depression Measure
  • PDSS-2 [ Time Frame: 8 weeks ]
    Sleep Measure for PD
  • ABC [ Time Frame: 8 weeks ]
    Measure of Balance Confidence
  • Functional Tasks Recording Form [ Time Frame: 8 weeks ]
    Measure of Activities of Daily Living
  • 10 meter walk test [ Time Frame: 8 weeks ]
    Gait speed
  • 6 minute walk test [ Time Frame: 8 weeks ]
    endurance measure
  • 5 times sit to stand [ Time Frame: 8 weeks ]
    Lower extremity strength measure
  • Mini-BESTest [ Time Frame: 8 weeks ]
    Balance Measure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Purpose of This Pilot Study is to Investigate the Impact of a Weekly 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.
Official Title  ICMJE BIG for Life: a Pilot Study
Brief Summary

BIG for Life is a a Community-based Weekly Exercise Group for Individuals With Parkinson's Disease With a Focus on Improving Ability to Walk, Balance, and Perform Daily Activities With an Emphasis on "Moving Big". The Purpose of This Pilot Study is to Investigate the Impact of a Weekly Exercise Group on Motor Function (i.e. Balance, Gait, Strength, Balance Confidence), Ability to Perform Activities of Daily Living, and Quality of Life Measures Such as Sleep and Depression in Individuals With Parkinson's Disease.

We will test the hypotheses that participation in this exercise group may:

  1. improve mobility level and balance confidence
  2. improve performance of activities of daily living
  3. improve quality of life, sleep, or depression
Detailed Description

BIG FOR LIFE PILOT STUDY PROTOCOL

Background Information

Parkinson's disease (PD) is a progressive neurodegenerative condition that affects cognitive and motor function, which negatively affects the quality of life of those afflicted with the disease. While proper medical management and medication can mitigate some symptoms through alteration of the underlying disease process, research has shown participation in an appropriate exercise program is critical to preserving cognitive and motor function.

The Lee Silverman Voice Treatment (LSVT) was originally developed in 1987 to improve voice quality and volume in those with Parkinson's Disease. The program has expanded to include a movement program for physical and occupational therapy called LSVT Big. This program is performed following a set protocol of one-hour, individual treatment sessions, performed four consecutive days per week for four consecutive weeks. This program focuses on enhancement of movement quality to improve mobility and functional skills through use of daily exercises, functional skill training, and gait training. The LSVT Big program has been found to be an effective treatment for those individuals with Parkinson's Disease, showing improvements in balance, mobility, ability to perform dual task, postural control, and reduction in fall risk.1,2,3 There has been little research performed to date regarding the use of the components of this program to assist with maintenance of function for participants who have successfully completed the LSVT Big program. The BIG for LIFE program is a newly developed community-based exercise group for those with Parkinson's Disease who have completed the LSVT Big program.

While the LSVT Big program is a well-established adjunct to standard medical and physical therapy protocols, with significant body of clinical research supporting its use. The BIG for LIFE program is built upon the foundation of LSVT Big protocol, and carries these principles into a community-based peer-group exercise program. However, as BIG for LIFE is newly introduced program, there is relatively little research evidence supporting its use as a continuation of the LSVT/Big protocol. This study seeks to build that evidence by evaluating the efficacy, safety and feasibility of BIG for LIFE to maintain motor and cognitive function following completion of LSVT/Big, and determine whether participation in a community-based peer-group exercise program will increase adherence to a home exercise program. Completing the proposed studies will provide needed evidence and will also provide information regarding continued use of the LSVT Big daily exercises upon discharging from skilled physical therapy.

There is significant research supporting the use of a home and community exercise programs as key strategies to slow the progression of PD and facilitate adaptations to this degenerative disorder. The BIG for LIFE program is an extension of the LSVT Big program that carries forward the key principles of large amplitude movements, dynamic vocalization and adapts them to a community-based peer-group exercise program. As such, BIG for LIFE allows participants to continue to work with a physical therapist on movement and balance strategies in a less intensive program than LSVT/Big, and reinforces strategies to maintain and improve ability to perform activities of daily living. Furthermore, BIG for LIFE exercise sessions are held in a group setting that encourages peer interaction and feedback, which can be an important aspect of understanding and addressing the psychosocial adversity many individuals with PD experience. Our study will obtain objective measures of motor performance, participant self-assessments of balance, activities of daily living, quality of life, depression, sleep and anecdotal evidence of participant experience with this program. Completion of the proposed research will provide much needed evidence supporting the use of this program, which may translate to improving quality of life for persons with PD.

Our proposed study will evaluate BIG for LIFE as a community exercise program, and will determine whether a weekly exercise session is adequate to maintain physical and cognitive function for a period of 8 weeks. It is reasonable that our proposed project could, in the future, be translated into a longitudinal, placebo-controlled trial evaluating whether BIG for LIFE is an effective intervention to favorably alter the degenerative progression of cognitive and motor function over a longer follow-up period.

Specific Objectives

The specific objective of this study is to investigate the impact of this weekly 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)

We 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
  3. that participation in this group will increase quality of life, sleep, or depression measures

Study Design/Procedures

We propose a single-site, observational pilot study. Study subjects will be recruited to participate in a weekly community-based Parkinson's exercise group. Prior to enrollment, we will obtain informed consent, and interview prospective candidates to determine eligibility: inclusion/exclusion criteria including medical history of PD and mobility level. If enrolled, study participants will complete a total of eight group exercise sessions. At the initial session, participants will undergo cognitive (Montreal Cognitive Assessment, MOCA 4), physical assessments (10 meter walk test, 6 minute walk test, 5 Times Sit to Stand, and the Mini Bestest 5) and routine baseline medical assessments (Appearance, Pulses, BP) and complete self-assessments regarding balance (Activities Balance Confidence Questionaire, ABC5) and quality of life (PDQ-396,PHQ-9, PDSS-27, functional tasks form); these assessments will be repeated at the final visit. During each of the visits 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 questionaire scores before and after completion of the 8-week 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 LSVT BIG.

This study's exercise group will be conducted by a two licensed Physical Therapists with certificates of specialization in Neurology and delivery of the LSVT Big program and student physical therapist, with career aspiration of specializing in neurologic physical therapy and and a specific interest in working with individuals with PD. As a collaborative research team the interest is in implementing and assessing community-based exercise programs for the PD population.

Enrolled subjects will participate in a 8-week series of peer group exercise sessions. Each class will last one hour and will be facilitated by a physical therapist and physical therapy students. The location of the exercise sessions is at 604 Old Liverpool Rd, Liverpool, NY 13088, site of the Rock Steady Boxing Gym. During each session, the daily exercises as part of the LSVT Big program will be performed and modified to the participant's ability level, along with performance of functional tasks stations (i.e. putting on a jacket, putting on a sock, etc.) which will rotate weekly to monthly, and gait tasks (i.e. forward, backwards, stepping over obstacles). Incidental health findings revealed during the medical assessment or throughout the duration of the study will be managed by referral back to the managing physician. (ie: depression, blood pressure concerns, etc). Health findings specifically related to depression as can be elicited with sensitive questions on the PHQ-9, will be tracked and referred back to the managing physician . If it is determined that the participant is a danger to themselves or others, emergency services will be contacted immediately.

Completion of this pilot study will provide key validating data testing the feasibility and safety of the BIG for LIFE program as a community-based intervention. Furthermore, our proposed study will provide a firm foundation upon which we could expand and improve the longitudinal and examination of the efficacy of BIG for LIFE as a means to mitigate progressive decline in cognitive, physical and motor function, with the ultimate goal of preserving quality of life in patients with PD.

Eligibility Criteria

We aim to recruit 20 subjects to our study, using a rolling enrollment process in which new participants will join ongoing exercise groups of up to 30 participants. Participants will be recruited by contacting local neurologists, support groups and PD specific exercise groups and providing brochures and flyers with recruitment information. Interested candidates will be contacted by the study team, and provided specific information about the study and the informed consent process. Applicants will be mailed information about the study as well as forms indicating willingness to participate and informed consent. Once enrolled, the participants will be scheduled for their weekly peer-group exercise sessions. At the first session, the participants will undergo cognitive assessment (Montreal Cognitive Assessment4) and physical assessments(10 meter walk test, 6 minute walk test, 5 Times Sit to Stand, Mini Bestest5) and complete questionaires (Parkinson Disease Quality Life 396, Activities Specific Balance Questionaire5, Patient Health Questionnaire, Parkinson's Disease Sleep Scale,7 and Functional Tasks Recording Form). Upon completion of the 8 week exercise program, assessments and questionaires will be repeated, and the participants will be interviewed to gain anectdotal 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.

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.

Statistical Methods/Data Analysis and Interpretation The aim of this study is to use quantitative analysis from scoring of self-assessments and physical assessments. Statistical methods and data analysis will be conducted by Upstate with support from the Center for Outcomes Research.

All physical, cognitive, and self-assessments will be collected by licensed physical therapists specializing in neurology and physical therapy students with oversight of licensed physical therapists. Pre- and post- intervention assessments will be collected (10 meter walk test, 6-minute walk test, 5 Times Sit to Stand, Mini Bestest, ABC, PHQ-9, PDSS-2, Functional Task Recording Form, PDQ-395,6,7) to determine functional changes during the study period. Data will be analyzed using repeated-measures statistics as appropriate, and will be subject to intermittent evaluation to determine statistical power of our study design. We will also collect data regarding the safety (e.g. falling at home or in-session) and feasibility (attendance and home exercise adherence). As PD is a neurodegenerative condition it is anticipated that some individuals, particularly those with a history of rapid symptomatic progression, may experience a decline in motor function during their enrollment. Our proposed study will follow the magnitude and trajectory of functional decline in our participants, allowing us to draw association between initial performance, independent exercise and physical activity levels and participant attendance and engagement. Furthermore, a questionnaire at the completion of the protocol will be provided, allowing for subjective assessment of participant experience and potential refinement of the protocol.

Schematic Diagram of Study Design

Once enrolled, the participants will be scheduled for their weekly peer-group exercise sessions. At the first session, the participants will undergo cognitive assessment (Montreal Cognitive Assement4 MOCA) and physical assessments(10 meter walk test, 6 minute walk test, 5 Times Sit to Stand, Mini Bestest5) and complete questionaires (Parkinson Disese Quality Life6 PDQ-39, Activities Specific Balance Questionaire5 ABC, Patient Heath Questionnaire PHQ-9, Parkinsons Disease Sleep Scale PDSS-27, and Functional Tasks Recording Form FT). Upon completion of the 8 week exercise program, assessments and questionaires will be repeated, and the participants will be interviewed to gain anectdotal insight into their experience with the program.

VISIT 1 VISIT 2-7 VISIT 8 Cognitive Assessment - MOCA Cognitive Assessment - MOCA Medical Assessment - vitals Medical - vitals pre/post exercise Medical Assessment - vitals Physical Assessments - 10 meter walk test; 6 minute walk test; 5 Times Sit to Stand; Mini BESTest Physical Assessments - 10 meter walk test; 6 minute walk test; 5 Times Sit to Stand; Mini BESTest Questionnaires - PDQ-39, ABC, PHQ-9, PDSS-2, FT Questionnaires - PDQ-39, ABC, PHQ-9, PDSS-2, FT Exit Survey/Interview

BIG for Life VISIT 1:

LSVT BIG exercises Functional Tasks Gait/Balance activities

BIG for Life VISIT 2-7:

LSVT BIG exercises Functional Tasks Gait/Balance activities

BIG for Life VISIT 8:

LSVT BIG exercises Functional Tasks Gait/Balance activities

References

  1. McDonnell M, et al. Lee Silverman Voice Treatment (LSVT)- BIG to improve motor function in people with Parkinson's disease: a systematic review and meta-analysis. Clinical Rehabilitation. 2018; 32(5): 607-618.
  2. Janssens J et al. Application of LSVT BIG intervention to address gait, balance, bed mobility and dexterity in people with Parkinson disease: a case series. Physical Therapy. 2014; 94(7): 1014-1023.
  3. Ebersbach E, et al. Comparing exercise in Parkinson's disease - the Berlin LSVT BIG study. Movement Disorder. 2010; 25 (12): 1902-1908.
  4. Phannarus H et al. Cognitive profiles and optical cut-offs for routine cognitive tests in elderly individuals with Parkinson's disease, Parkinson's disease dementia, Alzheimer's disease and normal cognition. Psychogeriatrics. 2019; doi: 10.1111/psyg.12451
  5. Bloem B et al. Measurement instruments to assess posture, gait, and balance in Parkinson's disease: Critique and recommendations. Movement Disorder. 2016; 31(9): 1342-1355.
  6. Martinez-Martin P, et al. Health-related quality-of-life sclaes in Parkinson's disease: critique and recommendations. Movement Disorder. 2011; 26(13): 237-280.
  7. Trenkwalder MD, et al. Parkinson's Disease Sleep Scale - Validation of the Revised Version PDSS-2. Movement Disorder. 2011; 26(4): 644-652.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Other: Exercise
Enrolled subjects will participate in a 8-week series of peer group exercise sessions. Each class will last one hour and will be facilitated by a physical therapist and physical therapy students. During each session, the daily exercises as part of the LSVT Big program will be performed and modified to the participant's ability level, along with performance of functional tasks stations (i.e. putting on a jacket, putting on a sock, etc.) which will rotate weekly to monthly, and gait tasks (i.e. forward, backwards, stepping over obstacles).
Study Arms  ICMJE Experimental: BIG for Life Exercise Group
This arm includes the entire cohort enrolled who will participate in the weekly one hour community exercise group for a total of 8 weeks
Intervention: Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 13, 2020
Estimated Primary Completion Date September 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Amy DeBlois, DPT 315-464-6885 debloisa@upstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090476
Other Study ID Numbers  ICMJE 1441170
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amy DeBlois, State University of New York - Upstate Medical University
Study Sponsor  ICMJE State University of New York - Upstate Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account State University of New York - Upstate Medical University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP