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Trial record 85 of 46062 for:    intensity

Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease (AEROPROTECT)

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ClinicalTrials.gov Identifier: NCT04046276
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: High Intensity Aerobic program Other: Conventional Physical Therapy Behavioral: Medium Intensity Aerobic program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
  • 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
Primary Purpose: Treatment
Official Title: Neuroprotective, Motor and Cognitive Impact of a Long-standing Aerobic Training Program in Parkinson's Disease. A Multicenter Comparison of the Effects of Two Aerobic Programs of Graded Intensities and a Conventional Physical Therapy Program Prolonged for 9 Months on Nigrostriatal, Motor and Cognitive Functions.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Conventional Physical Therapy
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
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

Sham Comparator: Medium Intensity Aerobic exercise (50% VO2 max)
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
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

Experimental: High Intensity Aerobic exercise
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
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




Primary Outcome Measures :
  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. [ Time Frame: at day 1 and 9 Months ]
    The MDS-UPDRS III Score is a subjective assessment of motor symptoms based on the addition of ordinal 1-4 scores.


Secondary Outcome Measures :
  1. Two-minute walking test at maximal speed [ Time Frame: at day 1, 9 Months and 12 Months ]
  2. Modified 20-meter up-and-go test (AT20) [ Time Frame: at day 1, 9 Months and 12 Months ]
  3. Global Mobility Task (GMT) [ Time Frame: at day 1, 9 Months and 12 Months ]
    time required to stand up off the floor

  4. Upper limb performance in activities of daily living (Mount Sinai Parkinsonism Impairment Rating Scale, MSPIR) [ Time Frame: at day 1, 9 Months and 12 Months ]
    three unimanual tasks on each side and six bimanual everyday living tasks all times

  5. Maximal aerobic capacity (VO2 max) [ Time Frame: at day 1, 9 Months and 12 Months ]
  6. Montreal Cognitive Assessment test (MoCA) [ Time Frame: at day 1, 9 Months and 12 Months ]
  7. Digit span task (forward and backward) [ Time Frame: at day 1, 9 Months and 12 Months ]
  8. Trail Making Test [ Time Frame: at day 1, 9 Months and 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046276


Contacts
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Contact: Jean-Michel GRACIES, MD, PhD +33 1 49 81 30 61 jean-michel.gracies@aphp.fr
Contact: Nicolas BAYLE, MD +33 1 49 81 30 61 nicolas.bayle@aphp.fr

Locations
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France
Henri Mondor Hospital Not yet recruiting
Créteil, France, 94010
Contact: Jean-Michel GRACIES, MD, PhD    +33 1 49 81 30 61    jean-michel.gracies@aphp.fr   
Contact: Nicolas BAYLE, MD    +33 1 49 81 30 61    nicolas.bayle@aphp.fr   
Sébastopol hospital Not yet recruiting
Reims, France, 51100
Contact: François Constant BOYER, MD,PH    +33 3 26 78 85 97    fboyer@chu-reims.fr   
Rangueil hospital Not yet recruiting
Toulouse, France, 31059
Contact: Marc LABRUNEE, MD    +33 5 61 32 28 01    labrunee.m@chu-toulouse.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Michel GRACIES, MD, PhD Assistance Publique Hôpitaux de Paris (AP-HP)

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04046276     History of Changes
Other Study ID Numbers: P140926
2015-A01345-44 ( Other Identifier: IDRCB )
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson's disease
Aerobic Exercises
High Intensity Training
Neuroprotection
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases