Objectives: To evaluate whether aerobic exercise leads to clinically relevant improvements in 1) motor and 2) non-motor symptoms as well as quality of life and physical fitness.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the UPDRS-MDS motor scale in OFF after 6 months.
Secondary outcome
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.
Background summary
PD patients are often physically inactive. A sedentary lifestyle is associated
with co-morbid complications, whereas exciting new reports suggest that
exercise might have the potential to suppress motor symptoms.
Hypothesis: We hypothesize that intensive aerobic exercise in sedentary PD
patients results in clinically relevant improvements of several disease-related
symptoms.
Study objective
Objectives: To evaluate whether aerobic exercise leads to clinically relevant
improvements in 1) motor and 2) non-motor symptoms as well as quality of life
and physical fitness.
Study design
phase 2, double-blind, randomized controlled trial
Intervention
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)
Study burden and risks
The baseline and follow up assessments will be performed at the Radboudumc and
will last approximately 5 hours (including 1 hour lunch break and a 15 min
coffee break). Almost all tests will be performed in the OFF stage of
dopaminergic medication, except for the maximal aerobic exercise test and the
UDPRS motor score that will be performed in both ON and OFF stage. Patients
will be thoroughly screened for cardiovascular risks before performing a
maximal aerobic exercise test and when considered harbouring a high
cardiovascular risk or when experiencing any exercise intolerance during the
test patients will be excluded to minimize the risk of an adverse event.
All subjects will perform a form of exercise at home for at least three times a
week for six months. The control subject will perform stretching exercises
which will be explained to them through an explanatory video*s and/or photo*s
and one home visit by a trained physiotherapist. The subjects in the
intervention group will cycle on a stationary bicycle for 30-45 minutes on a
target heart range (determined during the maximal exercise test). The home
trainer was chosen because it is a safe intervention (reduces risk of falls).
The bicycle will be placed at the patients home by the supplier and a member of
the research team will explain the exercise program. During the exercise a
visual feedback on their heart rate is provided that informs the patient
whether he/she is exercising in their prescribed heart rate zone. Data from the
bicycle is sent automatically to the researches after each training session
allowing the researchers to monitor the results and adjust settings when
needed. Additionally all patients will be supplied with a motivational App that
stimulates and reminds them to exercise, shows their achievements and provides
additional support by allowing them to invite their family and friends to
follow their achievements.
Reinier Postlaan 4
Nijmegen 6500HB
NL
Reinier Postlaan 4
Nijmegen 6500HB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47747.091.14 |
| OMON | NL-OMON26339 |