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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

an 8-week blended indoor-outdoor exercise program

an 8-week upper limb and hand exercise program

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EXPERIMENTAL

CONTROL

Arm Description

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

an eight-week training on upper limb stretching and strengthening, hand agility exercise, knot tying and Chinese calligraphy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes from baseline comfortable gait speed at post 4-week training, post 8-week training, 6- and 12-month follow-ups

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

Changes from baseline timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups

Changes from baseline five-times-sit-to-stand time at post 4-week training, post 8-week training, 6- and 12-month follow-ups

Changes from baseline one-leg stance time at post 4-week training, post 8-week training, 6- and 12-month follow-ups

Changes from baseline Activities-specific Balance Confidence Scale at post 4-week training, post 8-week training, 6- and 12-month follow-ups

Changes from baseline Parkinson's disease Questionnaire (PDQ-39) at post 4-week training, post 8-week training, 6- and 12-month follow-ups

Full Information

NCT ID

NCT01799681

First Posted

February 21, 2013

Last Updated

March 18, 2015

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT01799681

Brief Title

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EXPERIMENTAL

Arm Type

Experimental

Arm Description

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

Arm Title

CONTROL

Arm Type

Active Comparator

Arm Description

an eight-week training on upper limb stretching and strengthening, hand agility exercise, knot tying and Chinese calligraphy

Intervention Type

Behavioral

Intervention Name(s)

an 8-week blended indoor-outdoor exercise program

Intervention Description

stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice

Intervention Type

Behavioral

Intervention Name(s)

an 8-week upper limb and hand exercise program

Intervention Description

upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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 Pre-specified Outcome Measures:

Title

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

Title

Ratios of total and injurious non-fallers to fallers

Time Frame

12 months after intervention

Title

Total and Injurious fall rates

Time Frame

12 months after intervention

Title

The time to first fall and time to first injurious fall

Time Frame

12 months after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret KY Mak, PhD

Organizational Affiliation

The Hong Kong Polytechnic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hong Kong Polytechnic University

City

Hong Kong SAR

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26299751

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.

Results Reference

derived

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

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