- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805220
Nordic Walking as Gait Training for Frail Elderly
September 1, 2009 updated by: McGill University
Nordic Walking for Frail Elderly: a Randomized Pilot Trial
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.
Study Overview
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
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- Geriatric Day Hospital (GDH) at the Royal Victoria Hospital (RVH)
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Montreal, Quebec, Canada
- Richardson Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 years old or more
- undergoing rehabilitation program or living a residence facility
- medically stable or in their usually state of health.
Exclusion Criteria:
- severe cognitive impairments (short mini mental score less than 14/18)47
- unable to ambulate a minimum of 15 meters with or without aids
- without mobility restrictions as represented by a gait speed greater than 1.2 m/s
- 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
- pathological or musculoskeletal conditions of the upper extremity
- individuals unable to attend a minimum of eight weeks of intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Regular overground walking without poles
|
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:
|
Experimental: 2
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, 3 weeks follow-up, 8 weeks follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, 3 weeks follow-up, 8 weeks follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Mayo, BSc MSc PhD, McGill University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
December 8, 2008
First Submitted That Met QC Criteria
December 8, 2008
First Posted (Estimate)
December 9, 2008
Study Record Updates
Last Update Posted (Estimate)
September 2, 2009
Last Update Submitted That Met QC Criteria
September 1, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- NWS-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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