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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799681
• Other study ID #: approvalletter_20110823001
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: March 18, 2015
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: University Grants Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• an 8-week blended indoor-outdoor exercise program
stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice
• an 8-week upper limb and hand exercise program
upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		12 months after intervention	No
Other	Ratios of total and injurious non-fallers to fallers		12 months after intervention	No
Other	Total and Injurious fall rates		12 months after intervention	No
Other	The time to first fall and time to first injurious fall		12 months after intervention	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No