Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease

NCT04046276 | Unknown

• 2 other identifiers: P1409262015-A01345-44
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief Summary

In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (\>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Aerobic Exercises; High Intensity Training; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Change in MDS-UPDRS III Score (Movement Disorders Society - Unified Parkinson's Disease Rating Scale) in the " OFF " state between Day 1 and Month 9.

  The MDS-UPDRS III Score is a subjective assessment of motor symptoms based on the addition of ordinal 1-4 scores.

  at day 1 and 9 Months

Secondary Outcomes (8)

• Two-minute walking test at maximal speed

  at day 1, 9 Months and 12 Months

• Modified 20-meter up-and-go test (AT20)

  at day 1, 9 Months and 12 Months

• Global Mobility Task (GMT)

  at day 1, 9 Months and 12 Months

• Upper limb performance in activities of daily living (Mount Sinai Parkinsonism Impairment Rating Scale, MSPIR)

  at day 1, 9 Months and 12 Months

• Maximal aerobic capacity (VO2 max)

  at day 1, 9 Months and 12 Months

Study Arms (3)

Conventional Physical Therapy

PLACEBO COMPARATOR

Three sessions a week of hospital-based conventional physical therapy, all in presence and with the guidance of a registered physical therapist, for nine months

Other: Conventional Physical Therapy

Medium Intensity Aerobic exercise (50% VO2 max)

SHAM COMPARATOR

Three sessions a week of hospital-based Medium Intensity Aerobic exercise (50% VO2 max); on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months

Behavioral: Medium Intensity Aerobic program

High Intensity Aerobic exercise

EXPERIMENTAL

Three sessions a week of hospital-based High Intensity Aerobic exercise (70% VO2 max) on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months

Behavioral: High Intensity Aerobic program

Interventions

High Intensity Aerobic program BEHAVIORAL

Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months

High Intensity Aerobic exercise

Conventional Physical Therapy OTHER

Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months

Conventional Physical Therapy

Medium Intensity Aerobic program BEHAVIORAL

Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months

Medium Intensity Aerobic exercise (50% VO2 max)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of PD according to the UKPDSBB criteria
• Previous MRI available, to further help distinguish idiopathic PD from atypical parkinsonism Hoehn \& Yahr Stage 1-3 in OFF state
• Age \> 18
• Signed informed consent to participate in study

You may not qualify if:

• Patients lacking motivation or ability to participate in training sessions for 9 months, in the investigator's opinion
• Contra-indications to high-intensity aerobic training in the cardiologist's opinion
• Contra-indications to perchlorate de potassium or to the use of 123I-FP-CIT
• Concurrent severe co-morbidities
• Cognitive deficit limiting participation to the program in the investigator's opinion
• Montreal Cognitive Assessment test (MoCA)\<23
• Uninsured patient
• Participation in another ongoing interventional clinical trial (drug therapy, surgical treatment, another rehabilitation treatment, medical device)
• Pregnancy or current lactation, or no efficacious contraception during the 9 months of intervention.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Henri Mondor Hospital

Créteil, 94010, France

Location

Sébastopol hospital

Reims, 51100, France

Location

Rangueil hospital

Toulouse, 31059, France

Location

Related Publications (2)

• 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

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Michel GRACIES, MD, PhD

  Assistance Publique Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Michel GRACIES, MD, PhD

CONTACT

+33 1 49 81 30 61; jean-michel.gracies@aphp.fr

Nicolas BAYLE, MD

CONTACT

+33 1 49 81 30 61; nicolas.bayle@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Study participants will be unaware of the hypothesis. * All investigator assessors, clinical, cardiological, biomechanical or through SPECT \[123I\] beta-CIT striatal uptake measurements, will be unaware of the participant group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized study, three parallel groups (n= 7 or 8 per group and per center, over 3 centers): * Group 1 "Conventional Physical Therapy", CPT * Group 2 "Medium Intensity Aerobic program", MIA (50% VO2 max); * Group 3 "High Intensity Aerobic program", HIA (70% VO2 max); HIA and MIA groups are experimental groups and CPT group is the control group. Each group will attend 3 weekly 45-minute sessions at the hospital for 9 months.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)