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Completed

NCT Number: NCT01799681

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

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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong SAR, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

an 8-week blended indoor-outdoor exercise program

Behavioral

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

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2013
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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