Exercise as Treatment of Fatigue in Parkinson´s Disease

NCT06324422 | Recruiting DMC

• 1 other identifier: Fatigue & Parkinson's disease
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD). The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period). It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis).

Conditions

Parkinson's Disease

Keywords

Exercise therapy; Parkinson's disease; Rehabilitation; Aerobic exercise; Resistance exercise; Fatigue

Outcome Measures

Primary Outcomes (1)

• Change in Modified Fatigue Impact Scale

  Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The total score of the MFIS is the sum of the scores for the 21 items and ranges from 0 to 84. The ranges of scores for each subscale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

Secondary Outcomes (20)

• Change in Fatigue Severity Scale

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

• Change in Parkinson's Fatigue Scale

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

• Change in Parkinson's Disease Questionnaire 39

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

• Change in Baecke Habitual Physical Activity Questionnaire

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

• Change in Pitchburg Sleep Quality Index

  Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)

Study Arms (2)

Aerobic exercise group

EXPERIMENTAL

Participants must be clinically fatigued when enrolled and furthermore meet additional inclusion criteria.

Other: Aerobic exercise intervention

Waitlist control group/resistance exercise group

EXPERIMENTAL

Participants must be clinically fatigued when enrolled and furthermore meet additional inclusion criteria.

Other: Resistance exercise intervention

Interventions

Aerobic exercise intervention OTHER

Participants in this arm are randomized to perform 12 weeks of supervised high intensity progressive aerobic exercise comprising continuous and/or interval cycling-, rowing- or cross-trainer sessions, increasing from 30 minutes towards 60 minutes with intensity increasing from 65 to 90% of individual maximum heart rate. The 12 weeks of aerobic exercise are followed by 12 weeks of habitual lifestyle (follow up period).

Aerobic exercise group

Resistance exercise intervention OTHER

Participants in this arm are randomized to a 24-week waitlist control group. The control group will continue their habitual lifestyle throughout the 24 weeks. After 24 weeks, the waitlist control group will begin a 12 week supervised resistance exercise intervention comprising machine exercises in 3 to 5 sets with 2-3 minutes rest in between and a decrease from 12 to 6 repetitions in parallel with intensity increasing from 15RM (repetition maximum) to 8 RM.

Waitlist control group/resistance exercise group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 40 years
• Diagnosed with Idiopathic Parkinsons disease
• Stable in medical treatment for six month
• Able to transport themselves to and from exercise and testing sessions (with or without assistance)
• H\&Y score of three or lower

You may not qualify if:

• Performing high-intensity exercise more than two times per week
• Significant medical comorbidities such as cardiovascular, respiratory, orthopedic, metabolic, or other neurological disorders
• Cognitive dysfunction that prevents following or understanding instructions related to training and testing (answering questionnaires)
• Known depression or alcohol abuse

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Exercise Biology, Dep. of Public Health, Aarhus University

Aarhus, Central Jutland, 8000, Denmark

RECRUITING

Related Publications (25)

• Langeskov-Christensen M, Hvid LG, Jensen HB, Nielsen HH, Petersen T, Stenager E, Dalgas U. Efficacy of high-intensity aerobic exercise on common multiple sclerosis symptoms. Acta Neurol Scand. 2022 Feb;145(2):229-238. doi: 10.1111/ane.13540. Epub 2021 Oct 22.

  PMID: 34687036 BACKGROUND

• Riemenschneider M, Hvid LG, Ringgaard S, Nygaard MKE, Eskildsen SF, Petersen T, Stenager E, Dalgas U. Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES). BMJ Open. 2021 Jan 12;11(1):e043699. doi: 10.1136/bmjopen-2020-043699.

  PMID: 33436475 BACKGROUND

• Riemenschneider M, Hvid LG, Ringgaard S, Nygaard MKE, Eskildsen SF, Gaemelke T, Magyari M, Jensen HB, Nielsen HH, Kant M, Falah M, Petersen T, Stenager E, Dalgas U. Investigating the potential disease-modifying and neuroprotective efficacy of exercise therapy early in the disease course of multiple sclerosis: The Early Multiple Sclerosis Exercise Study (EMSES). Mult Scler. 2022 Sep;28(10):1620-1629. doi: 10.1177/13524585221079200. Epub 2022 Mar 16.

  PMID: 35296183 BACKGROUND

• Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.

  PMID: 15372591 BACKGROUND

• Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.

  PMID: 26358158 BACKGROUND

• Winward C, Sackley C, Meek C, Izadi H, Barker K, Wade D, Dawes H. Weekly exercise does not improve fatigue levels in Parkinson's disease. Mov Disord. 2012 Jan;27(1):143-6. doi: 10.1002/mds.23966. Epub 2011 Sep 27.

  PMID: 21953509 BACKGROUND

• Rios Romenets S, Anang J, Fereshtehnejad SM, Pelletier A, Postuma R. Tango for treatment of motor and non-motor manifestations in Parkinson's disease: a randomized control study. Complement Ther Med. 2015 Apr;23(2):175-84. doi: 10.1016/j.ctim.2015.01.015. Epub 2015 Feb 9.

  PMID: 25847555 BACKGROUND

• Solla P, Cugusi L, Bertoli M, Cereatti A, Della Croce U, Pani D, Fadda L, Cannas A, Marrosu F, Defazio G, Mercuro G. Sardinian Folk Dance for Individuals with Parkinson's Disease: A Randomized Controlled Pilot Trial. J Altern Complement Med. 2019 Mar;25(3):305-316. doi: 10.1089/acm.2018.0413. Epub 2019 Jan 9.

  PMID: 30624952 BACKGROUND

• Shulman LM, Katzel LI, Ivey FM, Sorkin JD, Favors K, Anderson KE, Smith BA, Reich SG, Weiner WJ, Macko RF. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. JAMA Neurol. 2013 Feb;70(2):183-90. doi: 10.1001/jamaneurol.2013.646.

  PMID: 23128427 BACKGROUND

• Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.

  PMID: 24991037 BACKGROUND

• Granziera S, Alessandri A, Lazzaro A, Zara D, Scarpa A. Nordic Walking and Walking in Parkinson's disease: a randomized single-blind controlled trial. Aging Clin Exp Res. 2021 Apr;33(4):965-971. doi: 10.1007/s40520-020-01617-w. Epub 2020 Jun 11.

  PMID: 32529596 BACKGROUND

• Atan T, Ozyemisci Taskiran O, Bora Tokcaer A, Kaymak Karatas G, Karakus Caliskan A, Karaoglan B. Effects of different percentages of body weight-supported treadmill training in Parkinson's disease: a double-blind randomized controlled trial. Turk J Med Sci. 2019 Aug 8;49(4):999-1007. doi: 10.3906/sag-1812-57.

  PMID: 31292107 BACKGROUND

• Cugusi L, Solla P, Serpe R, Carzedda T, Piras L, Oggianu M, Gabba S, Di Blasio A, Bergamin M, Cannas A, Marrosu F, Mercuro G. Effects of a Nordic Walking program on motor and non-motor symptoms, functional performance and body composition in patients with Parkinson's disease. NeuroRehabilitation. 2015;37(2):245-54. doi: 10.3233/NRE-151257.

  PMID: 26484516 BACKGROUND

• Ribas CG, Alves da Silva L, Correa MR, Teive HG, Valderramas S. Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial. Parkinsonism Relat Disord. 2017 May;38:13-18. doi: 10.1016/j.parkreldis.2017.02.006. Epub 2017 Feb 7.

  PMID: 28190675 BACKGROUND

• Dashtipour K, Johnson E, Kani C, Kani K, Hadi E, Ghamsary M, Pezeshkian S, Chen JJ. Effect of exercise on motor and nonmotor symptoms of Parkinson's disease. Parkinsons Dis. 2015;2015:586378. doi: 10.1155/2015/586378. Epub 2015 Feb 2.

  PMID: 25722915 BACKGROUND

• Michels K, Dubaz O, Hornthal E, Bega D. "Dance Therapy" as a psychotherapeutic movement intervention in Parkinson's disease. Complement Ther Med. 2018 Oct;40:248-252. doi: 10.1016/j.ctim.2018.07.005. Epub 2018 Jul 7.

  PMID: 30219460 BACKGROUND

• Herring MP, O'Connor PJ. The effect of acute resistance exercise on feelings of energy and fatigue. J Sports Sci. 2009 May;27(7):701-9. doi: 10.1080/02640410902777385.

  PMID: 19424902 BACKGROUND

• Lin I, Edison B, Mantri S, Albert S, Daeschler M, Kopil C, Marras C, Chahine LM. Triggers and alleviating factors for fatigue in Parkinson's disease. PLoS One. 2021 Feb 4;16(2):e0245285. doi: 10.1371/journal.pone.0245285. eCollection 2021.

  PMID: 33540422 BACKGROUND

• Alberts JL, Rosenfeldt AB. The Universal Prescription for Parkinson's Disease: Exercise. J Parkinsons Dis. 2020;10(s1):S21-S27. doi: 10.3233/JPD-202100.

  PMID: 32925109 BACKGROUND

• Elbers RG, Verhoef J, van Wegen EE, Berendse HW, Kwakkel G. Interventions for fatigue in Parkinson's disease. Cochrane Database Syst Rev. 2015 Oct 8;2015(10):CD010925. doi: 10.1002/14651858.CD010925.pub2.

  PMID: 26447539 BACKGROUND

• Siciliano M, Trojano L, Santangelo G, De Micco R, Tedeschi G, Tessitore A. Fatigue in Parkinson's disease: A systematic review and meta-analysis. Mov Disord. 2018 Nov;33(11):1712-1723. doi: 10.1002/mds.27461. Epub 2018 Sep 28.

  PMID: 30264539 BACKGROUND

• Nassif DV, Pereira JS. Fatigue in Parkinson's disease: concepts and clinical approach. Psychogeriatrics. 2018 Mar;18(2):143-150. doi: 10.1111/psyg.12302. Epub 2018 Feb 6.

  PMID: 29409156 BACKGROUND

• Port RJ, Rumsby M, Brown G, Harrison IF, Amjad A, Bale CJ. People with Parkinson's Disease: What Symptoms Do They Most Want to Improve and How Does This Change with Disease Duration? J Parkinsons Dis. 2021;11(2):715-724. doi: 10.3233/JPD-202346.

  PMID: 33459664 BACKGROUND

• Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.

  PMID: 30584159 BACKGROUND

• Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.

  PMID: 28150045 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cecilie Thrue, PhD student

CONTACT

+4520768102; ceth@ph.au.dk

Ulrik Dalgas, Professor

CONTACT

dalgas@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled multi-site trial with follow-up

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 22, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)