Clinical trial NCT01799681: The Effects of the Hopeful Outdoor Parkinson Exercise (HOPE) Program on Improving Balance Performance in Parkinsonian Non-fallers and Single Fallers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Changes from baseline comfortable gait speed at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
measure: 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
timeFrame: 12 months after intervention
measure: Changes from baseline timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
measure: Changes from baseline five-times-sit-to-stand time at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
measure: Changes from baseline one-leg stance time at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
measure: Changes from baseline Activities-specific Balance Confidence Scale at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
measure: Changes from baseline Parkinson's disease Questionnaire (PDQ-39) at post 4-week training, post 8-week training, 6- and 12-month follow-ups
timeFrame: 12 months after intervention
Other outcomes:
measure: Changes from baseline Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III at post 4-week training, post 8-week training, 6-and 12-month follow-ups
timeFrame: 12 months after intervention
measure: Ratios of total and injurious non-fallers to fallers
timeFrame: 12 months after intervention
measure: Total and Injurious fall rates
timeFrame: 12 months after intervention
measure: The time to first fall and time to first injurious fall
timeFrame: 12 months after intervention
Locations:
city: Hong Kong SAR
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Margaret KY Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong-Yu IS, Mak MK. Task- and Context-Specific Balance Training Program Enhances Dynamic Balance and Functional Performance in Parkinsonian Nonfallers: A Randomized Controlled Trial With Six-Month Follow-Up. Arch Phys Med Rehabil. 2015 Dec;96(12):2103-11. doi: 10.1016/j.apmr.2015.08.409. Epub 2015 Aug 20.