Nordic Walking as Gait Training for Frail Elderly

Frail Elderly Clinical Trial

Official title:

Nordic Walking for Frail Elderly: a Randomized Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805220
• Other study ID #: NWS-001
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: September 1, 2009
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frail Elderly

Intervention

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

Locations

Country	Name	City	State
Canada	Geriatric Day Hospital (GDH) at the Royal Victoria Hospital (RVH)	Montreal	Quebec
Canada	Richardson Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test 5 Meter Walk Test Activities-Specific Balance Confidence (ABC) Scale		Baseline, 3 weeks follow-up, 8 weeks follow-up	No
Secondary	Berg Balance Scale; CHAMPS; Lower Extremity Functional Scale; Visual Analogue Scale of Pain; EuroQol 5D.		Baseline, 3 weeks follow-up, 8 weeks follow-up	No

External Links

•   Pete Edwards and The American Nordic Walking System