Frail ElderlyPhase 2NCT00805220
Nordic Walking as Gait Training for Frail Elderly
A Phase 2 study testing Nordic Walking in people with Frail Elderly, run by McGill University at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Nordic Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old or more
- undergoing rehabilitation program or living a residence facility
- medically stable or in their usually state of health.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Geriatric Day Hospital (GDH) at the Royal Victoria Hospital (RVH)
Montreal, Quebec
Richardson Hospital
Montreal, Quebec
About this study
Official title: 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.
Read the 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).
- Conditions
- Frail Elderly
- Being tested
- Nordic Walking
- Keywords
- frail elderly walking capacity walk training Nordic Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic WalkingOther
Also called PoleStriding, Exerstriding
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Regular overground walking without poles Receives: Other: Nordic Walking |
| 2 | Experimental | Nordic Walking Receives: Other: Nordic Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test 5 Meter Walk Test Activities-Specific Balance Confidence (ABC) Scale
Measured: Baseline, 3 weeks follow-up, 8 weeks follow-up
Secondary outcomes (1)
Berg Balance Scale; CHAMPS; Lower Extremity Functional Scale; Visual Analogue Scale of Pain; EuroQol 5D.
Measured: Baseline, 3 weeks follow-up, 8 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Investigators
- Nancy Mayo, BSc MSc PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805220
- Sponsor's protocol ID
- NWS-001
- Status last verified
- Sep 2009
- First submitted
- 8 Dec 2008
- Last updated
- 2 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23066879
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Walking for Frail Elderly: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT00805220
- Acronym / sponsor ID
- NWS-001
- Conditions
- Frail Elderly
- Keywords
- frail elderly walking capacity walk training Nordic Walking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Nordic WalkingRegular overground walking without poles |
| 2 | Experimental | Other: Nordic WalkingNordic Walking |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years old or more
- undergoing rehabilitation program or living a residence facility
- medically stable or in their usually state of health.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic WalkingAlso: PoleStriding, ExerstridingWalking 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 | 1, 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
- Derived from this study: PubMed 23066879Figueiredo 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.
- Pete Edwards and The American Nordic Walking SystemLink provided by the sponsor.
Related trials for Frail Elderly
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Mayo, BSc MSc PhD principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nordic Walking in people with Frail Elderly, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.