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

NCT ID: NCT05357638

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2025-11-02

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.

Detailed Description

Next to complex motor deficits, people with Parkinson's disease and Multiple Sclerosis experience highly disabling non-motor symptoms; for example, anxiety and depression, cognitive decline, fatigue, and sleep problems. Physical training is increasingly recognized as an assisting and, importantly, safe therapy for these patients to alleviate disease burden. However, the optimal dose (i.e., type, frequency, intensity, duration) of exercise has not yet been established. This study aims to investigate differences in response patterns of motor and non-motor symptoms, blood-based biomarkers of neuroplasticity and neurodegeneration, as well as functional brain connectivity to eight weeks of high intensity interval training [2x/week, ~30 min/session], continuous aerobic training [2x/week, ~50 min/session], or movement advice [+3000 steps/day for 5 days/week monitored with an activity tracker]. Frequently repeated assessment of outcomes measures will be conducted.

Conditions

Parkinson Disease; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Training Group 1 (n=16)

High Intensity Interval Training

Group Type: EXPERIMENTAL

High Intensity Interval Training (HIIT)

Intervention Type: BEHAVIORAL

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

Physical Training Group 2 (n=16)

Continuous Aerobic Training

Group Type: EXPERIMENTAL

Continuous Aerobic Training (CAT)

Intervention Type: BEHAVIORAL

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

Physical Training Group 3 (n=16)

Movement Advice

Group Type: EXPERIMENTAL

Movement Advice

Intervention Type: 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

Interventions

High Intensity Interval Training (HIIT)

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

Intervention Type: BEHAVIORAL

Continuous Aerobic Training (CAT)

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

Intervention Type: BEHAVIORAL

Movement Advice

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• Stable medication regime for at least 4 weeks prior to inclusion
• Age >=18 years

Exclusion Criteria

• Participation in intensive exercise program in the month prior to inclusion
• Relapse in the month prior to inclusion (MS)
• Symptoms indicating cardiovascular, pulmonary, or metabolic disease or cardiovascular, pulmonary, or metabolic disease which are not under control with medication
• abnormal electrocardiography in rest

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Netherlands Brain Foundation

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Dr. Erwin E. H. van Wegen

Principal Investigator, Associate Professor Neurorehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erwin EH van Wegen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

Amsterdam UMC, location VU medical center

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Erwin EH van Wegen, Dr.

Role: CONTACT

e.vanwegen@amsterdamumc.nl

020-4440461

Facility Contacts

Erwin EH van Wegen, Dr.

Role: primary

e.vanwegen@amsterdamumc.nl

020-4440461

Elvira S Amaral Gomes, MSc

Role: backup

e.s.amaralgomes@amsterdamumc.nl

020-4444925

Related Links

http://www.hersenfit.amsterdam

Website of the trial

Other Identifiers

NL78096.029.21

Identifier Type: -

Identifier Source: org_study_id