Exercise to improve motor and non-motor symptoms in Parkinson’s disease
| ISRCTN | ISRCTN64657880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64657880 |
- Submission date
- 02/10/2024
- Registration date
- 04/10/2024
- Last edited
- 04/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
People living with Parkinson's disease (PD) may experience both motor and non-motor symptoms. Ample evidence indicates the benefits of exercise interventions in improving symptoms in patients with PD. This research aims to examine the effect of an exercise intervention on decreasing those symptoms to improve the quality of life of PD patients by using both objective measures and exploring patients' perspectives and inputs.
Who can participate?
Patients with a diagnosis of early to mid-stage PD who are aged between 40 to 80 years old
What does the study involve?
Participants in this study will be randomly assigned to either an LSVT BIG intervention group or a control group (without receiving the LSVT BIG during this study). The measures to be taken include both movement-related (such as mobility, and balance) and non-movement-related (e.g., fatigue) assessments. All participants will undergo the same measurements.
What are the possible benefits and risks of participating?
There is no direct benefit to the participants. However, the findings of this research are expected to contribute to evidence used to guide clinical management of this disease. Possible risks may be associated with falls in the performance of outcome measures such as mobility and balance evaluation. However, the risk level is lower than minimal as the tests will be administered by a licensed therapist, and a gait belt will be used to prevent any risk of falls.
Where is the study run from?
Impact Physical Therapy and Franklin Pierce University Arizona Doctor of Physical Therapy manage this study.
When is the study starting and how long is it expected to run for?
January 2024 to December 2025
Who is funding the study?
LSVT Global Inc.
Who is the main contact?
Dr Ruiping Xia, xiar@franklinpierce.edu
Contact information
Public, Scientific, Principal Investigator
14455 W Van Buren Street
A-100
Goodyear
85338
United States of America
| Phone | +1 6235182386 |
|---|---|
| xiar@franklinpierce.edu |
Public, Scientific, Principal Investigator
7727 W Deer Valley RD; STE 210
Peoria
85382
United States of America
| Phone | +1 4802980212 |
|---|---|
| thefferon@impactptaz.com |
Study information
| Study design | Mixed-methods study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Other therapist office |
| Study type | Treatment, Efficacy |
| Scientific title | LSVT-BIG: improving motor and non-motor symptoms in Parkinson’s disease: a mixed-method study |
| Study acronym | LSVT-BIG |
| Study objectives | LSVT-BIG treatment will improve motor and non-motor symptoms in patients with Parkinson’s disease. |
| Ethics approval(s) |
Approved 18/07/2024, Franklin Pierce University Institutional Review Board (IRB) (40 University Drive, Ridge, 03461, United States of America; +1 6038994294; Buddingtonl@franklinpierce.edu), ref: RX07182024 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Lee Silverman Voice Training (LSVT) BIG therapy is the intervention to be studied. LSVT BIG is an intensive, effective, one-on-one treatment delivered by an LSVT-BIG certified physical therapist created to help people with Parkinson's disease (PD) address walking, balance and other activities of daily living or even job-related tasks. LSVT-BIG includes one-hour session daily, four sessions per week, for four weeks in a row. Daily homework and carryover exercises are also provided. Participants with PD will be randomly assigned by a computer-generated program to either LSVT-BIG group or control group. |
| Intervention type | Behavioural |
| Primary outcome measure | The following primary outcome measures will be performed at baseline, immediate, 3, and 6 months post-intervention: 1. Non-motor symptoms will be measured by Movement Disorder Society (MDS) - Non-motor symptoms 2. Fatigue is measured by the Parkinson's Fatigue Scale 3. Motor symptoms will be measured by the MDS-Unified PD Rating Scale - Parts 2 and 3. 4. Motor function is measured by Mini-Balance Evaluation Systems Test (MiniBEST) and 5x Sit-To-Stand. |
| Secondary outcome measures | Quality of Life is measured by the Parkinson's Disease Questionnaire - 39 at baseline, immediate, 3, and 6 months post-intervention |
| Overall study start date | 01/01/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Ages at least 40 years old 2. Have a medical diagnosis of Parkinson’s disease (PD) at an early to mid-stage |
| Key exclusion criteria | 1. Those who had participated in an LSVT-BIG program in the last year 2. Those who are currently enrolled in another exercise intervention |
| Date of first enrolment | 01/11/2024 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Peoria
85382
United States of America
Sponsor information
Hospital/treatment centre
7727 W Deer Valley Rd Ste 210
Peoria
85382
United States of America
| Phone | +1 (623) 208-7575 |
|---|---|
| irb@franklinpierce.edu | |
| Website | https://impactptaz.com/peoria/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed topic-relevant journal (e.g., Journal of Neurologic Physical Therapy) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Tamara Hefferon at hefferont@franklinpierce.edu. De-identified data on the the primary outcomes as outlined previously at the different time points of interest outlined will be shared with the investigators of the study for statistical analysis. Participant consent will be obtained at the time of study enrollment. |
Editorial Notes
03/10/2024: Study's existence confirmed by the Institutional Review Board at Franklin Pierce University.
