Individuals with Parkinson’s Disease (PD) are often not referred to Physical Therapy (PT) until there are issues with mobility in later Hoehn and Yahr Stages. There have been no studies outlining the benefits of PT intervention in Stage I only. For persons with PD, deficits in motor function increase over time due to destruction of dopamine-producing cells. LSVT BIG, an exercise program for PD, has been shown to be effective in improving mobility. The purpose of this study was to assess participants functional improvement at a level of minimal clinically important difference (MCID) in one of four outcome measures: Gait Speed, Berg Balance Assessment, Functional Gait Assessment, and Unified Parkinson’s Disease Rating Scale Motor Section.
For persons diagnosed with Parkinson’s Disease (PD), deficits in motor function increase during the course of the disease, intensifying disability. These deficits are the result of loss of dopamine-secreting neurons in the motor circuits of the basal ganglia which are essential for control and coordination of movement [
A comprehensive exercise approach in treating PD used in Physical and Occupational Therapy is the “Lee Silverman Voice Treatment (LSVT) BIG”. This approach was developed and evaluated by Drs. Becky Farley and Gail Koshland. It began as a concept of “Learning and Training BIG” based on principles first described and researched for LSVT LOUD®, where the primary treatment focus was amplitude [
LSVT BIG has been shown to be effective in improving mobility for people with PD in a variety of stages of the disease [
The primary purpose of this study was to explore how LSVT BIG can impact individuals in Stage I of PD. Care providers need evidence that referral at early stages to a PT program such as LSVT BIG is beneficial [
This study was conducted at a hospital-based outpatient neurological rehabilitation clinic. Participants were referred to Physical Therapy from local neurologists and primary care physician clinics. Patients were eligible to participate if they were in Stage I of clinically probable idiopathic PD, could communicate in English, able to attend a community LSVT BIG exercise class, and willing to sign consent [
Participant demographics.
Characteristic | Statistic |
---|---|
Age (years), median (range) | 75 (51–82) |
Sex | |
Female | 5 |
Male | 4 |
Race | |
White | 9 |
Care partner available at home | 4 |
| 5 (0–11) |
| 6 (2–17) |
| 1 (0–2) |
0 | 1 |
1 | 5 |
2 | 3 |
| |
2 | 2 |
3 | 6 |
4 | 1 |
Eleven people presented with PD with symptoms of unilateral bradykinesia with hypokinesia. All potential participants reported changes in gait, balance, and decreased quality of life. Initial patient interview indicated they were in Stage I and found to be eligible for the study. Of those, nine provided written consent to participate in this study.
The examination completed by the Physical Therapist certified in LSVT BIG consisted of a semistructured interview and physical examination. Participants completed a questionnaire regarding their past medical history, current symptoms and goals, and past interventions (of note, no participants reported past PT for their PD symptoms). Subjective history was taken which included information about diagnosis, medication, social support, and functional limitations to be addressed in LSVT BIG intervention. Table
Clinical characteristics of participants.
ID | Chief complaints | Comorbidities | Patient goal | Time from diagnosis to start of LSVT BIG |
---|---|---|---|---|
1 | Muscle Stiffness, difficulty with walking and stairs, difficulty with upper extremity tasks | Irritable bowel syndrome, gastric reflux, hypertension, hyperlipidemia, osteopenia, skin cancer, urge incontinence, chronic obstructive pulmonary disease | “To improve symptoms, walk better, relax muscles” | 2 months |
2 | Poor posture, difficulty walking, decreased balance | Hypertension, obesity, low back pain, osteopenia, macular degeneration, bilateral rotator cuff surgery | “Improve walking and decrease symptoms” | 11 months |
3 | Fatigue, difficulty with fine motor skills, left upper extremity tremor | Depression | “Improve endurance of left arm, increase exercise” | 40 months |
4 | Difficulty with transfers and gait, freezing, left side tremor | Glaucoma, hypertension, left ankle surgery, hypothyroidism, cataracts | “Improved movement and increased strength” | 13 months |
5 | Lower extremity weakness, difficulty with gait | Prolactinoma | “Restore strength and flexibility” | 17 months |
6 | Slow Gait Speed, unsteady gait | Diabetes mellitus, diastolic heart failure, hypertension, atrial fibrillation, small bowel resection, hyperlipidemia, left knee and shoulder arthroscopy, lumbar surgery, total knee arthroplasty, iridotomy | “Improve balance and function” | 29 months |
7 | Neck and foot pain, fearful of falling | Bilateral total knee arthroplasty | “Get muscles stronger to get more balanced” | 3 months |
8 | Decreased arm swing, scapular pain, rigidity | None | “Loosen trap muscles and improve symptoms of PD” | 65 months |
9 | Sit to stand, buttoning shirt, poor handwriting | Hypertension, cardiac stent, endarterectomy, constipation, bladder issues, difficulty in hearing | “Learn how to do things better” | 53 months |
The objective tests and measures confirmed all participants were in Stage I of PD and indicated they were appropriate and would benefit from LSVT BIG intervention. Tables
The objective measures for gait and balance assessment included the primary outcomes of Gait Speed, Berg Balance Assessment, and Functional Gait Assessment (FGA), as well as a secondary outcome, the Four-Square Step Test (FSST). These were designated based on availability of MCID criteria. Table
Outcome measures (completed at baseline, after LSVT BIG, and 3 months after LSVT BIG).
Measure | Range | MCID or MDC |
---|---|---|
Gait Speed (meters/sec) | NA | 0.16 (MCID) [ |
Berg Balance Assessment | 0–56 | 4 points if initial score is 45–56, 5 points if the initial score is 35–44, 7 points if the initial score is 25–34, 5 points if the initial score is 0–24 (MCID) [ |
FGA | 0–30 | 8 (MCID) |
UPDRS, Motor Section | 0–56 | −2.5 points (MCID) [ |
Four-Square Step Test (secs) | NA | Not established at time of study |
PDQ-39, Mobility Domain | 0–156 | −12.24 (MDC) [ |
Knowledge Survey (baseline only) | 0–5 | Not applicable |
Primary outcomes and MCID.
ID | Gait Speed | FGA | Berg | UPDRS | Total MCID |
---|---|---|---|---|---|
1 | | | | | |
2 | | | | | |
3 | | | | | |
4 | | | | | |
5 | | | | | |
6 | | | | | |
7 | | | | | |
8 | | | | | |
9 | | | | | |
Total MCID | Post: 4 | Post: 3 | Post: 4 | Post: 7 | 8 participants achieved MCID in at least 1 measure |
3 mths: 5 | 3 mths: 3 | 3 mths: 4 | 3 mths: 7 |
Secondary outcomes.
ID | Four-Square Step Clockwise | Four-Square Step Counter | PDQ-9, Mobility | Knowledge survey |
---|---|---|---|---|
1 | 3.3, | 3.5, | 25, −7.5, | 42 |
2 | 5.1, 0.3, 1.1 | 5.3, | 7.5, 22.5, 351 | 5 |
3 | 3.1, | 2.8, 0, | 40, | 42 |
4 | 9, | 8.1, | 85, | 5 |
5 | 5.9, | 6.1, | 17.5, 5, −5 | 5 |
6 | 7.3, | 7.1, 1.3, | 32.5, | 4 |
7 | 12.5, | 12.3, | 62.5, | 5 |
8 | 4.2, | 4.09, | 20, | 5 |
9 | 6.1, | 5.6, | 5, 0, −51 | 5 |
| ||||
Total Improved | Total Improved | Total MDC | ||
Post: 8 | Post: 7 | Post: 5 | ||
3 mths: 6 | 3 mths: 7 | 3 mths: 5 |
Gait Speed is calculated as time required to complete a 30-foot walk and can help quantify bradykinesia with ambulation in PD [
The objective measures for this category included the primary outcome, the Unified Parkinson’s Disease Rating Scale III Motor Section (UPDRS), and the secondary outcome, the Parkinson’s Disease Questionnaire-39 (PDQ-39). These were based on availability of MCID criteria. The UPDRS Motor is a 14-item scale and is considered the “gold-standard” for experimental studies and medical management [
At baseline, participants were asked to complete a brief four question knowledge survey about PD to determine awareness of the disease. Three of the questions were derived from an article from Valldeoriola et al. with the addition of the fourth question by the investigators [
The participants attended a total of 16 sessions of one-on-one training with a therapist certified in the LSVT BIG approach and completed the intervention per the protocol. Sessions were one hour each, four times per week for four weeks [
LSVT BIG interventions described.
Task | Exercises | Progression |
---|---|---|
Maximal sustained exercises | Exercise 1: 8 repetitions floor to ceiling | Finger weights, flicks |
| ||
Repetitive standing movements | Exercise 3: 16 repetitions forward step | Starting with external support chair working towards no assistive device, adding cuff weights to limbs, larger weight shifts |
| ||
Functional components and hierarchy task | All did sit/stand and then 4 other functional components selected based on chief complaints | Adding cuff weights to limbs, reducing cues and shaping, increasing reps, increasing speed, changing support surface dynamics |
| ||
Hierarchy task | A sequence of functional components | Increasing reps, increasing speed, adding more complexity with props or functional items for the task |
| ||
BIG walking/gait training | Distance varied from 110′ to 825′, focus on longer strides with reciprocal arm swing and upright posture | Decrease use of AD, longer distances, outdoor surfaces, hiking poles, metronome, treadmill training, and reciprocal arm swing |
Participants were contacted by telephone every other week over the study period of four months. They were asked questions to explore their adherence to the recommended home exercise program. Barriers were discussed and participants were directed to talk with the Principal Investigators (PIs) when suboptimal adherence was noted. Participants were asked to track their adherence with exercise at home using a checklist throughout the study.
Participants were required to attend an LSVT BIG Community Exercise Class for three months, twice a month, for a total of six classes, following completion of LSVT BIG training. The classes consisted of LSVT BIG exercises, functional training, strength exercises, and balance activities. Attendance at these sessions was recorded.
Participants were successful with LSVT BIG if they achieved minimal clinically important difference (MCID) in functional improvement on at least one of four primary outcome measures: Gait Speed, Berg Balance Assessment, FGA, or UPDRS (Table
Tables
Over the initial four week period of training, data obtained through exercise adherence checklists indicated that the number of days missed for completion of home exercises was three or less. Participants 3 and 8 sustained minor injury unrelated to the study, and as a result they modified their exercises for one week. Participants exercised once instead of the recommended twice daily schedule on a few occasions. Seven of nine participants attended all community classes. Participant 2 attended five classes, and Participant 8 was unable to attend any classes due to conflicts with work.
Adherence was further explored through semistructured telephone interviews. Data obtained through telephone interviews during the initial four week period of training supported participants’ reports of adherence. Participants 1, 2, 3, 5, and 9 reported adherence to program as instructed. Participants 4 and 6 were adherent to exercises at a varied schedule of completing double the amount of exercises, one time a day. Participant 7 reported completing one set of exercises daily instead of two due to reported foot pain. Participant 8 was generally nonadherent during the initial training, reporting completing weekends only due to other life demands. Overall, impressions of adherence obtained through telephone interviews suggest adherence rates generally declined after the initial four weeks of exercise training.
After the initial four weeks, telephone interviews continued for the remainder of the study. Participant 2 was the only one who consistently reported completing exercises as recommended two times daily. Six participants (3, 4, 5, 6, 7, and 9) reported adherence at a varied schedule such as once a day, doubling or spacing exercises out throughout the day, or missing occasional days or weeks. Participant 8 reported variable adherence due to life demands and Parkinson’s symptoms.
In this study, the participants benefited from LSVT BIG as shown by improvements on at least one of the primary outcomes measures at a level of MCID: Gait Speed, Berg Balance Assessment, FGA, and/or UPDRS. These improvements were achieved after LSVT BIG training and were maintained at three months after training for 8 of 9 participants. The participants in this study reported improvements in quality of life as outlined in the PDQ-39. Their baseline reporting of symptoms and limitations was more significant than researchers originally anticipated for people who are in Stage I PD. Continued research of Stage I PD is urgent given that approximately 1.5 million people in the United States have PD and with the extension of life expectancy, the number of individuals with PD is expected to rise dramatically within the next twenty-five years [
We required attendance at a community class as a means of reinforcement of LSVT BIG training as well as encouraging adherence to a daily exercise routine. Our results at three months showed little or no loss in performance from the advances made after LSVT BIG training. Group-based exercise through community classes has been shown to increase quality of life for neurological conditions, especially PD [
Reliable methods for supporting adherence to home exercise programs are needed to help participants be successful in adopting a regular exercise routine and schedule. Participants were contacted every other week by phone and were encouraged to identify barriers to exercising routinely. Those who identified barriers were provided guidance in overcoming them. Additional research is needed to explore factors associated with PD and exercise adherence including elements such as barriers and facilitators to exercise adherence, exercise preferences, self-efficacy, exercise attitudes, and motivation. Research exploring strategies that clinicians can use to promote development of habits and routines related to exercise is also needed. Clinicians need to consider the complexities of adherence when providing recommendations [
Many participants come to Physical Therapy with limited knowledge on how effective exercise can be in treating their condition. Based on the knowledge survey administered as part of this study, Participants 1 and 3 did not think that exercise could help symptoms of PD. This may be due to lack of information that is available to people newly diagnosed with PD with regard to the role of exercise throughout the disease process. As stated previously, most participants are not referred for PT until they are experiencing falls or have a significant change in their functional ability. Educating care providers about potential role of exercise in PD is important in raising awareness to ameliorate symptoms and improve quality of life [
In this study, both the Principal Investigator and Coinvestigator, who are both Physical Therapists, delivered the LSVT BIG training. Since LSVT BIG training has a prescribed methodology and credentialing requirements, we are confident that participants received training as prescribed. However, their teaching techniques may have had some variations that could have affected learning and retention.
We did not screen for deficits in cognition prior to participation in this study, which may be an additional limitation [
Another limitation to this study was that Participant 8 was an outlier, but the researchers felt it was important to include his data to examine tests and measures that may have a ceiling effect in Stage I of PD. He was also included in the study results even though he had varied adherence to home program and community classes due to full-time work and other life demands with raising children. This can be a limitation with research and outcomes with Stage I PD as individuals are often more active in community and family roles compared with those in later stages of the disease.
At the time of this research study, there was little research related to the best evidence and tests for balance and gait in PD. For this reason, the Berg was chosen to assess balance because there was normative data for people with PD. Since that time, there has been further research regarding more specific tests and measures that are appropriate for multiple stages of PD by the American Physical Therapy Association. For example, this has led to further use of the Mini-BEST test in PD. Future research would be beneficial in determining usefulness in Stage I of PD including normative data.
Additional research is needed to show efficacy in LSVT BIG training in Stage I of PD, to explore adherence to exercise in this population and whether routine exercise can slow disease progression.
A poster presentation regarding this study and preliminary results was presented at APTA CSM 2014 and at the MN APTA Spring Conference 2014. The researchers were a collaborative team consisting of two physical therapists (DPT), one occupational therapist (OTR/L), and one scientific advisor (MS).
The authors have no conflict of interests.
The authors thank the Courage Kenny Foundation and the Mercy/Unity Hospital Foundations for grants to support this research and the Courage Kenny Research Center for scientific advising and mentorship. They also thank the participants of the study for their time and dedication. This project received funds through the Courage Kenny Rehabilitation Foundation.