Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson’s disease

Table 2 Study schedule and assessments

	t = wk 0	t = wk 1-2	t = wk 2-3	t = wk 26-27	t = wk 27-28
Activity/Assessment	Pre-study screening (phone)	Study visit 1 (Screening/Baseline)	@ home	Study visit 2 (post-intervention)	@ home
Inclusion/Exclusion criteria
Cardiovascular risk factors
Rose questionnaire	x
Physical exam & ECG		x		x
MMSE		x
LAPAQ outdoor	x
H&Y stage		x		x
Primary outcome
Motor symptoms
MDS-UPDRS III off		x		x
Secondary outcomes
Motor symptoms
MDS-UPDRS III on		x		x
MDS-UPDRS IV		x		x
TUG		x		x
Pegboard		x		x
Finger tap test		x		x
Mini-BESTest		x		x
Falls & Near-falls		x		x
Non-motor symptoms
TAP flexibility		x		x
TMT		x		x
MoCa		x		x
SCOPA-sleep			x		x
HADS			x		x
SCOPA-AUT			x		x
FSS			x		x
Quality of life
PDQ-39			x		x
Physical fitness
VO2max		x		x
6MWT		x		x
Adherence
Bike computer/motivational app data		Data is automatically collected after each workout on a secured server. After 6 months the data is archived and locked.

ECG = electrocardiogram. MMSE = Mini Mental State Examination, LAPAQ = Longitudinal aging study Amsterdam Physical Activity Questionnaire. H&Y = Hoehn & Yahr, MDS-UPDRS III/IV = Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale, motor section (III) and motor complications section (IV). TUG = Timed Up and Go test. Mini-BESTets = Mini-Balance Evaluation System Test. TAP = Test of Attentional Performance. TMT = Trial Making Test. MoCa = Montreal Cognitive Assessment. SCOPA-sleep = SCales for Outcomes in PArkinson’s disease, sleep section. SCOPA-aut = SCales for Outcomes in PArkinson’s disease, autonomic function section. FSS = Fatigue Severity Scale. PDQ-39 = 39-item Parkinson Disease Questionnaire VO2max = maximal amount of oxygen inhaled during maximal graded test. 6MWT = 6 Minute Walk Test.

ISSN: 1471-2377