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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Geriatric Day Hospital (GDH) at the Royal Victoria Hospital (RVH)
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Regular overground walking without poles
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
Experimental: 2
Nordic Walking
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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