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Nordic Walking as Gait Training for Frail Elderly

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ClinicalTrials.gov Identifier: NCT00805220
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
McGill University

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 9, 2008
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE December 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
6 Minute Walk Test 5 Meter Walk Test Activities-Specific Balance Confidence (ABC) Scale [ Time Frame: Baseline, 3 weeks follow-up, 8 weeks follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
Berg Balance Scale; CHAMPS; Lower Extremity Functional Scale; Visual Analogue Scale of Pain; EuroQol 5D. [ Time Frame: Baseline, 3 weeks follow-up, 8 weeks follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nordic Walking as Gait Training for Frail Elderly
Official Title  ICMJE Nordic Walking for Frail Elderly: a Randomized Pilot Trial
Brief Summary The elderly are the fastest growing proportion of the population. Ageism implies a decline of physical functions affecting functional and safe ambulation. Based on the ICF model intervening in walking capacity could have favourable impact on quality of life of frail elders. Over ground walking training is indicated as a possible exercise. However, to achieve positive results on walking capacity, an exercise-dose response is needed. A more intensive way of promoting walking training is to add skiing poles while walking, a technique called Nordic Walking (NW). This study will be the first to compare NW with usual walking training. It aims to estimate for frail elderly the relative efficacy in improving functional walking capacity of two gait training strategies: NW and usual walking training and explore its impact on fear of falling. This study hypothesized that participants receiving Nordic Walking will walk longer, faster and fear less. NW if proven effective will positively impact on the functional capacities and quality of life of frail elders and provide an more intense method of walking training.
Detailed Description This is a single blind, randomized, pilot trial designed to estimate the amount of change between two programs. Subjects will be randomized and stratified by setting into one of two groups, over ground walking training with poles (Nordic Walking) or traditional over ground walking training (without poles). Randomization will be computer generated using randomization scheme from the website Randomization.com at http://www.randomization.com Basic descriptive statistics will be used to characterize the participants and compare the two groups at baseline. Paired t-test will be used to estimate the efficacy of each intervention. Effects size of each interventions and its ratio will be calculated. Group-specific change score will be calculated to explore the impact of prognostic variables (age, gender, number of comorbities, baseline gait speed) on change of an outcome (with or without poles).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Frail Elderly
Intervention  ICMJE Other: Nordic Walking
Walking training with and without poles will be twice a week. The sessions last 20 minutes each and consist of walking, stretching and mobility exercises. This will last 8 weeks in a total of 16 sessions. A therapist will closely monitor your exercises and modify them according to your needs and comfort
Other Names:
  • PoleStriding
  • Exerstriding
Study Arms  ICMJE
  • Active Comparator: 1
    Regular overground walking without poles
    Intervention: Other: Nordic Walking
  • Experimental: 2
    Nordic Walking
    Intervention: Other: Nordic Walking
Publications * Figueiredo S, Finch L, Mai J, Ahmed S, Huang A, Mayo NE. Nordic walking for geriatric rehabilitation: a randomized pilot trial. Disabil Rehabil. 2013 Jun;35(12):968-75. doi: 10.3109/09638288.2012.717580. Epub 2012 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 8, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 65 years old or more
  2. undergoing rehabilitation program or living a residence facility
  3. medically stable or in their usually state of health.

Exclusion Criteria:

  1. severe cognitive impairments (short mini mental score less than 14/18)47
  2. unable to ambulate a minimum of 15 meters with or without aids
  3. without mobility restrictions as represented by a gait speed greater than 1.2 m/s
  4. moderate to severe limitations of upper extremity represented by a shoulder flexion range of motion (ROM) less than 90 degrees and extension less than 20 degrees; elbow flexion ROM less than 90 degrees; and with a poor grip judged by the ability to release a can of 5 cm diameter
  5. pathological or musculoskeletal conditions of the upper extremity
  6. individuals unable to attend a minimum of eight weeks of intervention.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805220
Other Study ID Numbers  ICMJE NWS-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nancy E. Mayo, BSc(PT), MSc, PhD, McGill University
Study Sponsor  ICMJE McGill University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nancy Mayo, BSc MSc PhD McGill University
PRS Account McGill University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP