Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799681
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Margaret Kit Yi Mak, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: an 8-week blended indoor-outdoor exercise program Behavioral: an 8-week upper limb and hand exercise program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months after intervention ]

Secondary Outcome Measures :
  1. Changes from baseline comfortable gait speed at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]
  2. 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 [ Time Frame: 12 months after intervention ]
  3. Changes from baseline timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]
  4. Changes from baseline five-times-sit-to-stand time at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]
  5. Changes from baseline one-leg stance time at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]
  6. Changes from baseline Activities-specific Balance Confidence Scale at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]
  7. Changes from baseline Parkinson's disease Questionnaire (PDQ-39) at post 4-week training, post 8-week training, 6- and 12-month follow-ups [ Time Frame: 12 months after intervention ]

Other Outcome Measures:
  1. 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 [ Time Frame: 12 months after intervention ]
  2. Ratios of total and injurious non-fallers to fallers [ Time Frame: 12 months after intervention ]
  3. Total and Injurious fall rates [ Time Frame: 12 months after intervention ]
  4. The time to first fall and time to first injurious fall [ Time Frame: 12 months after intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799681


Locations
Layout table for location information
China
The Hong Kong Polytechnic University
Hong Kong SAR, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Layout table for investigator information
Principal Investigator: Margaret KY Mak, PhD The Hong Kong Polytechnic University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Margaret Kit Yi Mak, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01799681    
Other Study ID Numbers: approvalletter_20110823001
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Keywords provided by Margaret Kit Yi Mak, The Hong Kong Polytechnic University:
randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases