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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS074343 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| University of Pittsburgh | OTHER |
| Rush University Medical Center | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) |
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The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.
The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Sham Comparator | Wait listed to moderate or vigorous exercise after 6 months of no exercise. |
|
| Vigorous Exercise | Experimental | Endurance exercise at 80-85% HR max, 4x/wk for 6 months. |
|
| Moderate Exercise | Experimental | Endurance exercise at 60-65% HR max, 4x/wk for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Exercise | Behavioral | Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise | To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol. | 9 to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score | Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Exercise Per Week | The number of days the participant exercised per week | 9 to 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Schenkman, PT, PhD | University of Colorado, Denver | Principal Investigator |
| Daniel Corcos, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| University of Illinois, Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
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Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales.
Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); |
| FG001 | Vigorous Exercise | Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. |
| FG002 | Moderate Exercise | Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); |
| BG001 | Vigorous Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise | To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol. | Only for participants who contributed heart rate monitor data. | Posted | Mean | 95% Confidence Interval | percentage of maximum heart rate | 9 to 26 weeks |
|
Adverse event data were collected monthly until the primary time point at 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charity G. Moore | University of Pittsburgh | 412-383-6630 | cgp22@pitt.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001480 | Basal Ganglia Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D000080874 | Synucleinopathies |
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| NIH |
| Northwestern University | OTHER |
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| Vigorous Exercise | Behavioral | Endurance exercise at 80-85% HR max, 4x/wk for 6 months. |
|
| No Intervention | Behavioral | No-exercise control (i.e., usual care); |
|
| Baseline and 6 months |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| 30428907 | Derived | Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z. |
| 29228079 | Derived | Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517. |
| 23770108 | Derived | Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14. |
| Missing assessment |
|
| Adverse Event |
|
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
| BG002 | Moderate Exercise | Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation | Sum of 27 items scored 0 to 4, minimum score is 0, maximum score is 108. Higher score indicates worse motor symptoms. | Mean | Standard Deviation | units on a scale |
|
| Total daily steps | Several participants did not wear the activity monitor devices for recording total number of daily steps. | Mean | Standard Deviation | steps per day |
|
| Hoehn and Yahr Stage | Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance | Count of Participants | Participants |
|
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
|
|
|
| Secondary | 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score | Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms. | Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included. | Posted | Mean | 95% Confidence Interval | units on the UPDRS Motor scale | Baseline and 6 months |
|
|
|
|
| Other Pre-specified | Number of Days of Exercise Per Week | The number of days the participant exercised per week | Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention. | Posted | Mean | 95% Confidence Interval | Number of days per week | 9 to 26 weeks |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 13 |
| 40 |
| EG001 | Vigorous Exercise | Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. | 0 | 43 | 0 | 43 | 28 | 43 |
| EG002 | Moderate Exercise | Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. | 0 | 45 | 2 | 45 | 24 | 45 |
| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stage 2 |
|
| The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation . | t-test, 1 sided | 0.03 | The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation). | Mean Difference (Final Values) | 1.2 | 1-Sided | 90 | 2.8 | The estimate is the difference between the control group and the moderate exercise group. The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis. | Other |