Parkinson DiseaseNCT04918342
Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease
A study testing Multidimensional Exercise Program in people with Parkinson Disease, run by Ithaca College at 1 site in United States.
Trial summary
This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multidimensional Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of idiopathic Parkinson disease
- been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
- be able to walk independently
- have a referral from a physician to participate in the program
- have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform
Who cannot join
- have any other neurological condition other than Parkinson disease
- have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
- demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
- have any musculoskeletal condition that affected their ability to participate in the exercise group
- score less than 24/30 on the Mini Mental Status Examination during the initial evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease
This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.
Read the detailed description
This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.
- Conditions
- Parkinson Disease
- Being tested
- Multidimensional Exercise Program
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Exercise ProgramOther
The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Individual Exercise Instruction | Active comparator | The participant will receive individual exercise instruction. Receives: Other: Multidimensional Exercise Program |
| Group Exercise Instruction | Experimental | The participant will receive the instruction in a group of up to 9 other participants. Receives: Other: Multidimensional Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Mini-Balance Evaluation Systems Test" Score
This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.
Measured: Prior to and after the 8 week intervention.
Change in "Five Times Sit to Stand" test time
For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.
Measured: Prior to and after the 8 week intervention.
Secondary outcomes (4)
Change in 10 meter walk test
This outcome measure examines gait speed at comfortable and fast speeds. This will be performed using the Gait Rite mat which will collect information about gait characteristics, including step length, step width, and gait symmetry as well. A faster time is associated with better balance and walking ability.
Measured: Prior to and after 8 week intervention.
Change in Six Minute Walk Test Distance
This outcome examines gait endurance by measuring the distance walked over 6 minutes on a level surface. A greater number of meters on the test is associated with better walking endurance.
Measured: Prior to and after 8 week intervention.
Change in Parkinson Disease Questionnaire-39 score
This is a self report quality of life measure designed for individuals with Parkinson disease. There are 8 subsections which can be reported individually and the score can be calculated as a summary score out of 100%. A lower percentage is associated with lower disability related to Parkinson disease.
Measured: Prior to and after 8 week intervention.
Change in Self Efficacy for Exercise Scale score
This measures a person's confidence that they will exercise in a variety of situations.The score ranges from 0 to 90 with a higher score associated with a higher self efficacy for exercise behavior.
Measured: Prior to and after 8 week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start7 Jun 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either exercise individually with a physical therapist or in a group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ithaca College
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah Fishel, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918342
- Sponsor's protocol ID
- 271
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04918342
- Acronym / sponsor ID
- 271
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ithaca CollegeUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.
Detailed description
This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to either exercise individually with a physical therapist or in a group.
| Arm | Type | Receives |
|---|---|---|
| Individual Exercise Instruction | Active comparator | Other: Multidimensional Exercise ProgramThe participant will receive individual exercise instruction. |
| Group Exercise Instruction | Experimental | Other: Multidimensional Exercise ProgramThe participant will receive the instruction in a group of up to 9 other participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a diagnosis of idiopathic Parkinson disease
- been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
- be able to walk independently
- have a referral from a physician to participate in the program
- have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform
Key exclusion criteria (5 listed)
- have any other neurological condition other than Parkinson disease
- have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
- demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
- have any musculoskeletal condition that affected their ability to participate in the exercise group
- score less than 24/30 on the Mini Mental Status Examination during the initial evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional Exercise ProgramThe multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring. | Other | Group Exercise Instruction, Individual Exercise Instruction |
Primary outcome
Change in "Mini-Balance Evaluation Systems Test" Score
Time frame: Prior to and after the 8 week intervention.
This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.
Change in "Five Times Sit to Stand" test time
Time frame: Prior to and after the 8 week intervention.
For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.
4 secondary outcomes
Change in 10 meter walk test
Time frame: Prior to and after 8 week intervention.
Change in Six Minute Walk Test Distance
Time frame: Prior to and after 8 week intervention.
Change in Parkinson Disease Questionnaire-39 score
Time frame: Prior to and after 8 week intervention.
Change in Self Efficacy for Exercise Scale score
Time frame: Prior to and after 8 week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Fishel principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Exercise Program in people with Parkinson Disease, run by Ithaca College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Mini-Balance Evaluation Systems Test" Score (time frame: Prior to and after the 8 week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.