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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44535

Enrollment

130

Registered

2014-05-07

Start date

2015-02-02

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyokinetic-rigid syndrome Parkinson's disease

Interventions

Patients will be randomized to (a) cycling on a stationary home trainer, combined with virtual reality and gaming elements (exergaming group, n=65)

or (b) stretching exercises without aerobic component (active control group, n=65)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the UPDRS-MDS motor scale in OFF after 6 months.	—

Secondary

Measure	Time frame
The secondary outcomes will be the UPDRS-MDS motor scale in ON state after 6 months, and other motor and non-motor symptoms after 6 months, physical fitness (VO2max, 6MWT) and quality of life after 6 months and adherence rate.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)