The Park-in-Shape study: a randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson*s disease.

Phase 2

Completed

• Conditions: hyokinetic-rigid syndrome; Parkinson's disease; 10028037

• Registration Number: NL-OMON44535
• Lead Sponsor: eurologie

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-05-25
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1) Idiopathic Parkinson*s disease, according to the UK Brain Bank criteria, diagnosed by a neurologist
2) H&Y stage *2 tested in OFF
3) Age 30-75 years
4) Sedentary lifestyle (insufficient aerobic physical activity, as defined by the current American College of Sports Medicine (ACSM) recommendations for older adults).
5) Both medicated and unmedicated patients are eligible, if they:
* Receive a stable dopaminergic medication dose (both levo-dopa and/or a dopamine agonist are allowed) for one month before the study
* Are umedicated and deemed unlikely to start treatment within the next month by their treating neurologist

Exclusion Criteria

1) Use of beta-blockers
2) Use of anti-psychotics
3) Inability to cycle or perform stretching exercises due to (other) neurologic or orthopedic co-morbidities
4) Inability to fill out questionnaires or perform a computer task (i.e due to poor vision, inability to read Dutch (illiteracy or foreign language)
5) Psychiatric diseases, including major depressive disorder, severe or moderate depressive episode or any form of psychosis, diagnosed by a psychiatrist in the last year.
6) No internet at home
7) MMSE <24
8) Contra-indications for aerobic exercise including diagnosed cardiac diseases (for instance but not exclusive: unstable angina, heart block, arrhythmia*s, uncontrolled hypertension), diagnosed but poorly controlled diabetes mellitus or pulmonary diseases (e.g. but not exclusive COPD, exertional asthma, pulmonary emphysema).
9) Unavailable for more than 10% (approximately 2.5 weeks) of the 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the UPDRS-MDS motor scale in OFF after 6 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes will be the UPDRS-MDS motor scale in ON state after 6<br /><br>months, and other motor and non-motor symptoms after 6 months, physical fitness<br /><br>(VO2max, 6MWT) and quality of life after 6 months and adherence rate. </p><br>