Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body

NCT05357638 | Unknown DMC

• 1 other identifier: NL78096.029.21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

People with Parkinson's disease and Multiple Sclerosis experience disabling motor and non-motor symptoms, which respond insufficiently to medication. To adequately alleviate disease burden, physical training is increasing acknowledged as an assisting therapy; however, the optimal dose of exercise in unknown.

Conditions

Parkinson Disease; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in anxiety and depressive symptoms

  The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale

  Baseline (week 0), week 4, week 12, week 16

Secondary Outcomes (24)

• Change in disease severity

  Baseline (week 0), week 4, week 12, week 16

• Change in cognitive function (i.e., ability to inhibit cognitive interference)

  Baseline (week 0), week 4, week 12, week 16

• Change in cognitive function (i.e., mental flexibility)

  Baseline (week 0), week 4, week 12, week 16

• Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions)

  Baseline (week 0), week 4, week 12, week 16

• Change in fatigue

  Baseline (week 0), week 4, week 12, week 16

Study Arms (3)

Physical Training Group 1 (n=16)

EXPERIMENTAL

High Intensity Interval Training

Behavioral: High Intensity Interval Training (HIIT)

Physical Training Group 2 (n=16)

EXPERIMENTAL

Continuous Aerobic Training

Behavioral: Continuous Aerobic Training (CAT)

Physical Training Group 3 (n=16)

EXPERIMENTAL

Movement Advice

Behavioral: Movement Advice

Interventions

High Intensity Interval Training (HIIT) BEHAVIORAL

8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer

Physical Training Group 1 (n=16)

Continuous Aerobic Training (CAT) BEHAVIORAL

8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer

Physical Training Group 2 (n=16)

Movement Advice BEHAVIORAL

Weekly step goal, monitored using an activity tracker, +3000 steps/day for 5 days/week, step goal is based on average step count in the 4 weeks of baseline prior to the intervention

Physical Training Group 3 (n=16)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Parkinson's Disease (PD) or Progressive Multiple Sclerosis (MS)
• Hoehn \& Yahr stage \<4 (PD), Expanded Disability Status Scale score \<6 (MS)
• Anxiety and/or depressive symptoms; Hospital Anxiety and Depression Scale (HADS) score \>=8 points on HADS-A and/or HADS-D
• Sufficient cognitive ability to understand training instructions; Montreal Cognitive Assessment score \>21 points
• Able to participate in intensive physical training, no contra-indications for exercise
• Age \>=18 years

You may not qualify if:

• Symptoms indicating cardiovascular, pulmonary, or metabolic disease or cardiovascular, pulmonary, or metabolic disease which are not under control with medication
• abnormal electrocardiography in rest

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Netherlands Brain Foundation: collaborator

Study Sites (1)

Amsterdam UMC, location VU medical center

Amsterdam, North Holland, 1081HZ, Netherlands

RECRUITING

Related Links

• Website of the trial

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erwin EH van Wegen, Dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erwin EH van Wegen, Dr.

CONTACT

020-4440461; e.vanwegen@amsterdamumc.nl

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor Neurorehabilitation

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 3, 2022
• Study Start: May 2, 2022
• Primary Completion: May 2, 2025
• Study Completion: November 2, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

NL (1)