Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02230267
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2014-08-27
Brief Title:
High-intensity Exercise and Fall Prevention Boot Camp for Parkinsons Disease
Sponsor:
University of Nevada Las Vegas
Organization:
University of Nevada Las Vegas
Study Overview
Official Title:
High-intensity Exercise and Fall Prevention Boot Camp for Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Several animal and human epidemiologic studies have provided evidence that exercise may be neuroprotective in Parkinsons disease PD Exercise may forestall diagnosis and in the case of those who have already been diagnosed with PD it may slow the observed neurodegeneration Unfortunately because this line of research is in early stages there is little evidence to indicate what biological mechanisms underlie the neuroprotection that is conferred with exercise Toward this end it is possible that an interaction between endogenous antioxidant enzymes inflammatory processes and reactive oxygen species may be associated with exercise improvements in PD
One of the most common reasons for premature death in PD is falls Several meta-analyses have concluded that exercise training programs focused on balance andor strength training are effective at improving aspects of balance Taken together the current body of evidence suggests that exercise may be neuroprotective and balancestrength training may decrease the likelihood of a fall The combination of these efficacious treatment modalities exercise and balancestrength training in a comprehensive treatment approach to improve PD symptoms and balance has been previously reported at relatively mild or moderate exercise intensities Because recent research has suggested that patients with PD may benefit more from more physically intense programs we are proposing a more aggressive approach with regard to exercise intensity and frequency in the present trial The primary purpose of this study is to determine the feasibility and safety of a high intensity exercise approach to PD A secondary purpose is to determine the trajectory of change in outcomes over the duration of the trial from a high intensity fall prevention program It is hoped that a signal of efficacy will allow this trial to progress to a comparative effectiveness trial An important innovative design element is collecting biological assays to better understand the mechanism underlying the anticipated clinical improvements
Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp HIBC in patients with PD by analyzing adherence and whether they achieve minimum Centers for Disease Control exercise standards 150 minwk moderate level aerobic exercise strengthening at least two times per week for the duration of the trial Aim 2 is to determine if participation in an 8-week HIBC under the direction of a physical therapist is safe for individuals with PD Secondary Aim 3 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for several physical outcomes falls per physical activity ratio balance efficacy motor activity fatigue muscle strength bone health cognitionmood and quality of life Secondary Aim 4 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for biological outcomes anti-inflammatory cytokines and anti-oxidant enzymes An additional exploratory aim will be an analysis of BDNF val66val val66met met66met polymorphisms to determine if there is a differential response to exercise
This trial is innovative because it utilizes a high intensity comprehensive exercise treatment approach aerobic exercise strengthening and balance training To our knowledge there have been no trials of individuals with PD who have participated in a trial of this intensity in a group boot camp setting Another innovative design element is the use of three novel assessments biological assays of pro- and anti-inflammatory cytokines endogenous anti-oxidant enzymes and a novel assessment of falls falls per physical activity ratio
Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual care control group standard low intensity group therapy class under the direction of physical therapists Each group will have 15 participants with a 15 patient-to-therapist ratio The HIBC will be 15 hours daily Monday through Friday Participants will be required to attend 3 out of the 5 days The protocol of the HIBC will include the following exercise components A 30 minutes of moderate-high intensity aerobic exercise B 15 minutes of strengthening the major muscle groups C 15 minutes of balance training and D 15 minutes of interspersed rest and stretching Participants will rotate through these four exercise components Participants will have one baseline test and assessments at the 2-week 4 week 8-week and 6-month points Outcomes of the primary aims Aim 1 and Aim 2 will be frequency counts of participation adverse events and compliance with exercise The outcomes for the secondary aims will include measures of balance and falls physical capacity fatigue exercisephysical activity behavior and biological assays
One of the most common reasons for premature death in PD is falls Several meta-analyses have concluded that exercise training programs focused on balance andor strength training are effective at improving aspects of balance Taken together the current body of evidence suggests that exercise may be neuroprotective and balancestrength training may decrease the likelihood of a fall The combination of these efficacious treatment modalities exercise and balancestrength training in a comprehensive treatment approach to improve PD symptoms and balance has been previously reported at relatively mild or moderate exercise intensities Because recent research has suggested that patients with PD may benefit more from more physically intense programs we are proposing a more aggressive approach with regard to exercise intensity and frequency in the present trial The primary purpose of this study is to determine the feasibility and safety of a high intensity exercise approach to PD A secondary purpose is to determine the trajectory of change in outcomes over the duration of the trial from a high intensity fall prevention program It is hoped that a signal of efficacy will allow this trial to progress to a comparative effectiveness trial An important innovative design element is collecting biological assays to better understand the mechanism underlying the anticipated clinical improvements
Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp HIBC in patients with PD by analyzing adherence and whether they achieve minimum Centers for Disease Control exercise standards 150 minwk moderate level aerobic exercise strengthening at least two times per week for the duration of the trial Aim 2 is to determine if participation in an 8-week HIBC under the direction of a physical therapist is safe for individuals with PD Secondary Aim 3 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for several physical outcomes falls per physical activity ratio balance efficacy motor activity fatigue muscle strength bone health cognitionmood and quality of life Secondary Aim 4 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for biological outcomes anti-inflammatory cytokines and anti-oxidant enzymes An additional exploratory aim will be an analysis of BDNF val66val val66met met66met polymorphisms to determine if there is a differential response to exercise
This trial is innovative because it utilizes a high intensity comprehensive exercise treatment approach aerobic exercise strengthening and balance training To our knowledge there have been no trials of individuals with PD who have participated in a trial of this intensity in a group boot camp setting Another innovative design element is the use of three novel assessments biological assays of pro- and anti-inflammatory cytokines endogenous anti-oxidant enzymes and a novel assessment of falls falls per physical activity ratio
Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual care control group standard low intensity group therapy class under the direction of physical therapists Each group will have 15 participants with a 15 patient-to-therapist ratio The HIBC will be 15 hours daily Monday through Friday Participants will be required to attend 3 out of the 5 days The protocol of the HIBC will include the following exercise components A 30 minutes of moderate-high intensity aerobic exercise B 15 minutes of strengthening the major muscle groups C 15 minutes of balance training and D 15 minutes of interspersed rest and stretching Participants will rotate through these four exercise components Participants will have one baseline test and assessments at the 2-week 4 week 8-week and 6-month points Outcomes of the primary aims Aim 1 and Aim 2 will be frequency counts of participation adverse events and compliance with exercise The outcomes for the secondary aims will include measures of balance and falls physical capacity fatigue exercisephysical activity behavior and biological assays
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None