Treatment Protocol for PD Fatigue Management With CBT

PD is the second most common neurodegenerative disorder in the United States. Although PD is
typically classified as a movement disorder, the non-motor symptoms (NMS) also have a
negative impact on quality of life. Among the NMS, fatigue is one of the most reported and
bothersome symptoms, even at the early stage of the disease. Currently there are not any
clear pharmacological or rehabilitative recommendations for managing PD related fatigue.

The purpose of this study is to evaluate the feasibility and effectiveness of a developed
treatment protocol specifically adapted to the Parkinson's population to address fatigue
symptoms based on the best available evidence. This is a one-group, pre-post, feasibility
study. It is hypothesized that an establishment of a proper sleep hygiene routine and a
moderate- to intensive-exercise routine three times a week will decrease Parkinson's disease
(PD) related fatigue and improve health-related quality of life. The treatment protocol
focuses on assisting individuals with PD experiencing fatigue to improve sleep hygiene habits
and establish physical exercise routine using cognitive behavioral therapy in a group format.
Through this study, the designed program will be evaluated to determine if it will decrease
self-perceived fatigue level and to improve health-related quality of life among community
dwelling people with PD.

Inclusion Criteria:

1. All subjects must be diagnosed with PD, without the diagnosis of Lewy Body dementia.
Atypical parkinsonism such as Progressive Supranuclear Palsy, Corticobasal
Degeneration, and Multiple System Atrophy are excluded.

2. All participants of the program are community dwelling.

3. Subjects must age between 21 and 80. There is no gender limitation.

4. All subjects report feeling sense of fatigue.

5. Because the intervention involves encouraging individuals to participate in
highly-intense physical exercise or multimodal moderately-intense physical exercise,
cardiovascular clearance from each participant's physician (either primary care,
internist, or cardiologist) is required. See attachment for cardiovascular clearance
letter.

6. Because cognitive behavioral therapy will be used in the interventions, and safety
judgment is required when choosing an appropriate physical exercise during
interventions, participants must present with adequate cognitive capacity. The
Montreal Cognitive Assessment (MoCA) will be used to determine if the individual meets
the cognitive criteria. MoCA score must be 24 or above, or 21 to 23 with an accompany
of a caregiver to participate (MoCA total score is 30). In PD, individuals with mild
neurocognitive disorder (NCD), with MoCA score 21 to 23, are able to perform everyday
activities independently, although with greater effort, compensatory strategies, or
accommodation

Exclusion Criteria:

1. MoCA score 22 or below

2. Unable to obtain physician clearance for exercise participation

3. Diagnosis of Lewy Body dementia. Atypical parkinsonism