Effects of Exercise on Long-Range Autocorrelations in Parkinson's Disease

NCT02419768 | Unknown DMC

• 1 other identifier: IONS - Warlop - 01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The parkinsonian gait is characterized by reducted stride length and gait speed, postural disorders (with a high risk of falling) and a modification of stride duration variability. This variability can be assessed by its magnitude (SD and CV) and its temporal organization (long-range autocorrelations). Healthy human gait presents with an interdependency between consecutive cycles that can span over hundreds of strides (long-range autocorrelations). Numerous observations plead for a relation between long-range autocorrelations and functional abilities of the system. Complementary to drugs, rehabilitation becomes an important way to treat PD. The aim of our study is to assess by a controlled, randomized, single blinded clinical study, the effect of physical exercise on stride duration variability, neurological impairments and walking abilities of parkinsonian patients. Physical exercise program will include 30 sessions spread over 15 weeks following the guidelines. Long-range correlations analysis, including the study of Hurst and α exponents, will be performed on a minimum of 512 consecutive cycles. Finally, the functional assessment of the parkinsonian patient will be done according to International Classification of Functioning Disability and Health (ICF).

Conditions

Parkinson's Disease

Keywords

Long-range autocorrelations; Variability; Physical Exercise; Parkinson's Disease; ICF

Outcome Measures

Primary Outcomes (1)

• Balance Evaluation Systems Test (BESTest)

  Change from baseline in balance measures at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

Secondary Outcomes (7)

• Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)

  Change from baseline in MDS-UPDRS at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

• Six Minute Walk Distance (6-MWD)

  Change from baseline in exercise tolerance at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

• 10 Meter Walk Test (10-MWT)

  Change from baseline in walking speed, step lenght and cadence at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

• Long-range autocorrelations

  Change from baseline in long-range autocorrelations at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

• Instrumented gait analysis

  Change from baseline in gait parameters (kinematic, kinetic, electromyographic and energetic) at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

Study Arms (2)

Physical Exercise

EXPERIMENTAL

All patients will receive a circuit-group training including a specific work of balance, posture, gait, fitness, dual tasks and stretching.

Other: Physical Exercise

Control

NO INTERVENTION

All patients will not change their physical activities

Interventions

Physical Exercise OTHER

The physical exercise program will include 30 sessions of 60 minutes (twice a week). According to the recent guidelines, the program will include a specific work on balance, posture, gait, fitness, dual tasks and stretching.

Physical Exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis idiopathic Parkinson according to the Brain Bank criteria of the United Kingdom Parkinson's Disease Society
• Disease severity according to modified Hoehn \& Yahr stages I to IV
• Absence of dementia Minimal Mini Mental State Examination score of 24 or higher
• Stable drug usage in the last 4 weeks
• Adequate vision and hearing, achieved using corrective lenses and/or hearing aid if required

You may not qualify if:

• Severe co-morbidity, other neurological problems, acute medical problems (e.g. MI, diabetes) and joint problems affecting mobility
• Unpredictable "Off"-periods (score \>2, MDS-UPDRS item 4.5)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Université catholique de Louvain - Cliniques universitaires Saint-Luc

Woluwé-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

Related Publications (24)

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• 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.

  PMID: 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Warlop T, Detrembleur C, Buxes Lopez M, Stoquart G, Lejeune T, Jeanjean A. Does Nordic Walking restore the temporal organization of gait variability in Parkinson's disease? J Neuroeng Rehabil. 2017 Feb 21;14(1):17. doi: 10.1186/s12984-017-0226-1.

  PMID: 28222810 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Thibault B. Warlop, Doctor

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Lejeune, Professor

CONTACT

+32 2 764 16 48; thierry.lejeune@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

BE (1)