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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 02 01; 75(2):219-226.JN

Abstract

Importance

Parkinson disease is a progressive neurologic disorder. Limited evidence suggests endurance exercise modifies disease severity, particularly high-intensity exercise.

Objectives

To examine the feasibility and safety of high-intensity treadmill exercise in patients with de novo Parkinson disease who are not taking medication and whether the effect on motor symptoms warrants a phase 3 trial.

Design, Setting, and Participants

The Study in Parkinson Disease of Exercise (SPARX) was a phase 2, multicenter randomized clinical trial with 3 groups and masked assessors. Individuals from outpatient and community-based clinics were enrolled from May 1, 2012, through November 30, 2015, with the primary end point at 6 months. Individuals with idiopathic Parkinson disease (Hoehn and Yahr stages 1 or 2) aged 40 to 80 years within 5 years of diagnosis who were not exercising at moderate intensity greater than 3 times per week and not expected to need dopaminergic medication within 6 months participated in this study. A total of 384 volunteers were screened by telephone; 128 were randomly assigned to 1 of 3 groups (high-intensity exercise, moderate-intensity exercise, or control).

Interventions

High-intensity treadmill exercise (4 days per week, 80%-85% maximum heart rate [n = 43]), moderate-intensity treadmill exercise (4 days per week, 60%-65% maximum heart rate [n = 45]), or wait-list control (n = 40) for 6 months.

Main Outcomes and Measures

Feasibility measures were adherence to prescribed heart rate and exercise frequency of 3 days per week and safety. The clinical outcome was 6-month change in Unified Parkinson's Disease Rating Scale motor score.

Results

A total of 128 patients were included in the study (mean [SD] age, 64 [9] years; age range, 40-80 years; 73 [57.0%] male; and 108 [84.4%] non-Hispanic white). Exercise rates were 2.8 (95% CI, 2.4-3.2) days per week at 80.2% (95% CI, 78.8%-81.7%) maximum heart rate in the high-intensity group and 3.2 (95% CI, 2.8-3.6; P = .13) days per week at 65.9% (95% CI, 64.2%-67.7%) maximum heart rate in the moderate-intensity group (P < .001). The mean change in Unified Parkinson's Disease Rating Scale motor score in the high-intensity group was 0.3 (95% CI, -1.7 to 2.3) compared with 3.2 (95% CI, 1.4 to 5.1) in the usual care group (P = .03). The high-intensity group, but not the moderate-intensity group, reached the predefined nonfutility threshold compared with the control group. Anticipated adverse musculoskeletal events were not severe.

Conclusions and Relevance

High-intensity treadmill exercise may be feasible and prescribed safely for patients with Parkinson disease. An efficacy trial is warranted to determine whether high-intensity treadmill exercise produces meaningful clinical benefits in de novo Parkinson disease.

Trial Registration

clinicaltrials.gov Identifier: NCT01506479.

Authors+Show Affiliations

Physical Therapy Program, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora.Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania.Division of Geriatric Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora. Geriatric Research Education and Clinical Center, Veterans Affairs Eastern Colorado Health Care System, Denver.Department of Neurology, Rush University Medical Center, Chicago, Illinois.Office of the Dean, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania.Department of Neurology, Rush University Medical Center, Chicago, Illinois.Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania.Physical Therapy Program, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora. Geriatric Research Education and Clinical Center, Veterans Affairs Eastern Colorado Health Care System, Denver.Department of Neurology, School of Medicine, University of Colorado Anschutz Medical, Campus, Aurora.Department of Neurology, School of Medicine, University of Colorado Anschutz Medical, Campus, Aurora.Geriatric Research Education and Clinical Center, Veterans Affairs Eastern Colorado Health Care System, Denver. Division of Endocrinology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora.Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania.Department of Rehabilitation Services, University of Illinois Hospital Health Sciences System, Chicago.Department of Neurology, Northwestern University, Chicago, Illinois.Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29228079

Citation

Schenkman, Margaret, et al. "Effect of High-Intensity Treadmill Exercise On Motor Symptoms in Patients With De Novo Parkinson Disease: a Phase 2 Randomized Clinical Trial." JAMA Neurology, vol. 75, no. 2, 2018, pp. 219-226.
Schenkman M, Moore CG, Kohrt WM, et al. 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;75(2):219-226.
Schenkman, M., Moore, C. G., Kohrt, W. M., Hall, D. A., Delitto, A., Comella, C. L., Josbeno, D. A., Christiansen, C. L., Berman, B. D., Kluger, B. M., Melanson, E. L., Jain, S., Robichaud, J. A., Poon, C., & Corcos, D. M. (2018). Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurology, 75(2), 219-226. https://doi.org/10.1001/jamaneurol.2017.3517
Schenkman M, et al. 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 02 1;75(2):219-226. PubMed PMID: 29228079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. AU - Schenkman,Margaret, AU - Moore,Charity G, AU - Kohrt,Wendy M, AU - Hall,Deborah A, AU - Delitto,Anthony, AU - Comella,Cynthia L, AU - Josbeno,Deborah A, AU - Christiansen,Cory L, AU - Berman,Brian D, AU - Kluger,Benzi M, AU - Melanson,Edward L, AU - Jain,Samay, AU - Robichaud,Julie A, AU - Poon,Cynthia, AU - Corcos,Daniel M, PY - 2017/12/12/pubmed PY - 2019/9/10/medline PY - 2017/12/12/entrez SP - 219 EP - 226 JF - JAMA neurology JO - JAMA Neurol VL - 75 IS - 2 N2 - Importance: Parkinson disease is a progressive neurologic disorder. Limited evidence suggests endurance exercise modifies disease severity, particularly high-intensity exercise. Objectives: To examine the feasibility and safety of high-intensity treadmill exercise in patients with de novo Parkinson disease who are not taking medication and whether the effect on motor symptoms warrants a phase 3 trial. Design, Setting, and Participants: The Study in Parkinson Disease of Exercise (SPARX) was a phase 2, multicenter randomized clinical trial with 3 groups and masked assessors. Individuals from outpatient and community-based clinics were enrolled from May 1, 2012, through November 30, 2015, with the primary end point at 6 months. Individuals with idiopathic Parkinson disease (Hoehn and Yahr stages 1 or 2) aged 40 to 80 years within 5 years of diagnosis who were not exercising at moderate intensity greater than 3 times per week and not expected to need dopaminergic medication within 6 months participated in this study. A total of 384 volunteers were screened by telephone; 128 were randomly assigned to 1 of 3 groups (high-intensity exercise, moderate-intensity exercise, or control). Interventions: High-intensity treadmill exercise (4 days per week, 80%-85% maximum heart rate [n = 43]), moderate-intensity treadmill exercise (4 days per week, 60%-65% maximum heart rate [n = 45]), or wait-list control (n = 40) for 6 months. Main Outcomes and Measures: Feasibility measures were adherence to prescribed heart rate and exercise frequency of 3 days per week and safety. The clinical outcome was 6-month change in Unified Parkinson's Disease Rating Scale motor score. Results: A total of 128 patients were included in the study (mean [SD] age, 64 [9] years; age range, 40-80 years; 73 [57.0%] male; and 108 [84.4%] non-Hispanic white). Exercise rates were 2.8 (95% CI, 2.4-3.2) days per week at 80.2% (95% CI, 78.8%-81.7%) maximum heart rate in the high-intensity group and 3.2 (95% CI, 2.8-3.6; P = .13) days per week at 65.9% (95% CI, 64.2%-67.7%) maximum heart rate in the moderate-intensity group (P < .001). The mean change in Unified Parkinson's Disease Rating Scale motor score in the high-intensity group was 0.3 (95% CI, -1.7 to 2.3) compared with 3.2 (95% CI, 1.4 to 5.1) in the usual care group (P = .03). The high-intensity group, but not the moderate-intensity group, reached the predefined nonfutility threshold compared with the control group. Anticipated adverse musculoskeletal events were not severe. Conclusions and Relevance: High-intensity treadmill exercise may be feasible and prescribed safely for patients with Parkinson disease. An efficacy trial is warranted to determine whether high-intensity treadmill exercise produces meaningful clinical benefits in de novo Parkinson disease. Trial Registration: clinicaltrials.gov Identifier: NCT01506479. SN - 2168-6157 UR - https://www.unboundmedicine.com/medline/citation/29228079/Effect_of_High_Intensity_Treadmill_Exercise_on_Motor_Symptoms_in_Patients_With_De_Novo_Parkinson_Disease:_A_Phase_2_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/jamaneurol.2017.3517 DB - PRIME DP - Unbound Medicine ER -