NCT01799681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

February 21, 2013

Last Update Submit

March 18, 2015

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

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

    12 months after intervention

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (2)

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

CONTROL

ACTIVE COMPARATOR

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

Interventions

an 8-week blended indoor-outdoor exercise programBEHAVIORAL

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

EXPERIMENTAL
an 8-week upper limb and hand exercise programBEHAVIORAL

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

CONTROL

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong SAR, China

Location

Related Publications (3)

  • 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.

    PMID: 38588457DERIVED

  • 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.

    PMID: 36602886DERIVED

  • 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.

    PMID: 26299751DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Margaret KY Mak, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 27, 2013

Study Start

August 1, 2011

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

CN(1)