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Parkinson's DiseaseNCT01799681

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

A study testing an 8-week blended indoor-outdoor exercise program and an 8-week upper limb and hand exercise program in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)… Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Parkinson's Disease
What is being tested?
an 8-week blended indoor-outdoor exercise program and an 8-week upper limb and hand exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
Aug 2011to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Hong Kong Polytechnic University

    Hong Kong SAR

Other trials in China

About this study

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

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.

Read the 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.

Being tested
an 8-week blended indoor-outdoor exercise program, an 8-week upper limb and hand exercise program
Keywords
randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • an 8-week blended indoor-outdoor exercise programBehavioural

    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 programBehavioural

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

Study groups in NCT01799681
Study groupRoleWhat they receive
EXPERIMENTALExperimentala 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
Receives: Behavioral: an 8-week blended indoor-outdoor exercise program
CONTROLActive comparatoran eight-week training on upper limb stretching and strengthening, hand agility exercise, knot tying and Chinese calligraphy
Receives: Behavioral: an 8-week upper limb and hand exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after intervention

Secondary outcomes (7)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 12 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799681
Sponsor's protocol ID
approvalletter_20110823001
Status last verified
Mar 2015
First submitted
21 Feb 2013
Last updated
20 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PubMed 38588457

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

  • 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.

    PubMed 26299751

Questions about this trial

What is this clinical trial studying?

A study testing an 8-week blended indoor-outdoor exercise program and an 8-week upper limb and hand exercise program in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01799681, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.

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