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

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: Multiple Sclerosis; Parkinson Disease

Treatments: Behavioral: Movement Advice; Behavioral: High Intensity Interval Training (HIIT); Behavioral: Continuous Aerobic Training (CAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05357638

NL78096.029.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Physical Training Group 1 (n=16)

Experimental group

Description:

High Intensity Interval Training

Treatment:

Behavioral: High Intensity Interval Training (HIIT)

Physical Training Group 2 (n=16)

Experimental group

Description:

Continuous Aerobic Training

Treatment:

Behavioral: Continuous Aerobic Training (CAT)

Physical Training Group 3 (n=16)

Experimental group

Description:

Movement Advice

Treatment:

Behavioral: Movement Advice