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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: an 8-week blended indoor-outdoor exercise program; Behavioral: an 8-week upper limb and hand exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL; 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; stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice
Active Comparator: CONTROL; 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; upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
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
Ratios of total and injurious non-fallers to fallers	12 months after intervention
Total and Injurious fall rates	12 months after intervention
The time to first fall and time to first injurious fall	12 months after intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Margaret KY Mak, PhD, The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 24, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: approvalletter_20110823001