The Effects of the Hopeful Outdoor Parkinson Exercise (HOPE) Program on Improving Balance Performance in Parkinsonian Non-fallers and Single Fallers

Study Overview
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Brief Summary
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To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be effective in improving balance performance, physical functions, gait parameter, balance confidence, health-related quality-of-life, disease-specific motor performance and fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.

Detailed Description
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Previous studies demonstrated that multi-modal balance training program was effective in improving balance performance in people with PD. However they did not include all the balance domains and outdoor fall-prone activities have been overlooked. We designed a task- and context-specific balance training program based on the framework of the Balance Evaluation Systems Test (BESTest) to target all six balance domains including biomechanical constraints, stability limits and verticality, anticipatory postural adjustments, reactive postural responses, sensori-motor integration and dynamic gait control.

Official Title
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The Effects of the Hopeful Outdoor Parkinson Exercise (HOPE) Program on Improving Balance, Gait and Functional Performance in Parkinsonian Non-fallers and Single Fallers - a Randomized Controlled Trial With 12-month Follow-up

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: an 8-week blended indoor-outdoor exercise program
* Behavioral: an 8-week upper limb and hand exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with PD by a neurologist (Fahn and Elton, 1987); aged 30 to 85 years; at modified Hoehn and Yahr (H&Y) stage 1.5 to 3 (Hoehn and Yahr ,1967; Goetz et al., 2004); able and willing to give written consent for participation in the study; living at home in the community; able to walk independently for 30 metres with or without an assistive device. Exclusion Criteria: any neurological conditions other than PD; significant musculoskeletal or cardiopulmonary diseases; other disorders that may affect balance or locomotion; taken any structured behavioral or exercise programs in the past 3 months or they are receiving regular physical rehabilitation at present; unstable condition on anti-parkinsonian medications; surgical interventions for PD; communication or cognitive deficits with mini-mental state examination, (MMSE) <24/30 (Folstein et al., 1975); a history of more than two falls in the previous 12 months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL<br>a 4-week indoor and 4-week outdoor balance training with stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice | Behavioral: an 8-week blended indoor-outdoor exercise program<br>* stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice<br>|
| Active Comparator: CONTROL<br>an eight-week training on upper limb stretching and strengthening, hand agility exercise, knot tying and Chinese calligraphy | Behavioral: an 8-week upper limb and hand exercise program<br>* upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline Balance Systems Evaluation Test total and subsection scores at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline comfortable gait speed at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline dual task timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline five-times-sit-to-stand time at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline one-leg stance time at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline Activities-specific Balance Confidence Scale at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 
| Changes from baseline Parkinson's disease Questionnaire (PDQ-39) at post 4-week training, post 8-week training, 6- and 12-month follow-ups |  | 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls