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Physical activity for people with Parkinson's disease and Multiple Sclerosis: effect on body and mind

Phase 2
Recruiting
Conditions
Parkinson's disease
Multiple Sclerosis
10028037
Registration Number
NL-OMON49908
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
48
Inclusion Criteria

1. diagnosis of Parkinson's disease (PD) or Multiple Sclerosis (MS); 2. Hoehn &
Yahr stage <4 (PD), EDSS score <6 (MS); 3. symptoms of disturbed affect,
including anxiety and depression [HADS score >=8 on anxiety and/or depression
subscale]; 4. able to participate in physical exercise program (i.e., no
history of heart programs, no symptms that might indicate heart problems (e.g.,
disturbed resting ECG), no other major health issues); 5. sufficient cognitive
ability to comprehend training instructions [MoCA score >21]; 6. stable
medication regime for at least four weeks; and 7. age >=18 years

Exclusion Criteria

1. participation in physical exercise program <1 month prior; 2. for people
with Multiple Sclerosis, relapse <1 month prior; 3. psychiatric,
musculoskeletal, or metabolic disorders prohibiting participation in physical
exercise program; 4. complaints of cardiovascular, pulmonary, and/or metabolic
abnormalities or cardiovascular, pulmonary, and/or metabolic abnormalities tgat
are not well controlled with medication, following the Lausanne protocol
(questionnaire, physical examination, cardiogram), in accordance with the
protocol on Kwaliteitsnet 'Bewegingslab ISL: beslisboom inspanningstest
spiro-ergometrie-REV, versie 1' at the department of Rehabilitation Medicine of
Amsterdam UMC location VUmc; 5. abnormal resting ECG; and 6. suicidal ideation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Anxiety and depression (HADS)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Disease severity (UPDRS, EDSS)<br /><br>Cognition (Stroop, TMT, SDMT)<br /><br>Fatigue (CIS-20r)<br /><br>Sleep quality (ISI)<br /><br>Well-being/disease impact (PDQ-8, MSIS)<br /><br>Quality of life (SF-36)<br /><br>Fysieke prestatie (10MWT, TUG, NHPT)<br /><br>ADL (NEADI)<br /><br>Fysieke activiteit (PASIPD)<br /><br>Hersennetwerk connectiviteit (MRI)</p><br>
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