Movement DisordersPhase 1/2NCT00037167
Effects of Exercise Poles on Older Adults During Exercise Walking
A Phase 1/2 study testing Exercise poles in people with Movement Disorders and Aging, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders, Aging
- What is being tested?
- Exercise poles
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Apr 2007
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80
- Normal gait
Who cannot join
- Inability to walk continuously for 5 minutes
- Contraindication from a personal physician
- Height over 6'2" or weight over 200 lbs (due to limitations of existing pole design)
- Mild to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Physical Education, Biomechanics Lab
Muncie, Indiana, 47306
About this study
Official title: Impact of Running Poles on Older Adult Exercise Walking
This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking.
Read the detailed description
Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype versions of the running poles. Preliminary results, after 3 months of testing, indicate the poles are safe and effective. Phase 2 will use improved versions of the poles, which are currently in development, with a group of around 125-150 subjects over a longer length of time (12 months). Changes in walking gait quality, balance, strength, body composition, exercise adherence, and subjective perceptions of wellness will be assessed before, during, and after the 12 month exercise session.
- Conditions
- Movement Disorders, Aging
- Being tested
- Exercise poles
- Keywords
- Fall-Prevention, Balance, Musculoskeletal Systems, Protective Devices, Gait, Equilibrium, Accidental Falls, Frail Elderly
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise polesDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startSep 2001
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ball State University
- Investigators
- Martin van Breems, Principal investigator, Martinus Van Breems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037167
- Sponsor's protocol ID
- R44AR048029
- Other IDs
- NIAMS-071
- Status last verified
- Apr 2009
- First submitted
- 16 May 2002
- Last updated
- 9 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Running Poles on Older Adult Exercise Walking
- ClinicalTrials.gov ID
- NCT00037167
- Acronym / sponsor ID
- R44AR048029
- Conditions
- Movement Disorders, Aging
- Keywords
- Fall-Prevention, Balance, Musculoskeletal Systems, Protective Devices, Gait, Equilibrium, Accidental Falls, Frail Elderly
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Collaborators
- Ball State University
- Study start
- Sep 2001
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 17 May 2002 (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.
This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking.
Detailed description
Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype versions of the running poles. Preliminary results, after 3 months of testing, indicate the poles are safe and effective. Phase 2 will use improved versions of the poles, which are currently in development, with a group of around 125-150 subjects over a longer length of time (12 months). Changes in walking gait quality, balance, strength, body composition, exercise adherence, and subjective perceptions of wellness will be assessed before, during, and after the 12 month exercise session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65-80
- Normal gait
Key exclusion criteria (4 listed)
- Inability to walk continuously for 5 minutes
- Contraindication from a personal physician
- Height over 6'2" or weight over 200 lbs (due to limitations of existing pole design)
- Mild to severe cognitive impairment
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 |
|---|---|---|
| Exercise poles | Device | – |
Primary outcome
Not reported in the source record.
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 9 Apr 2009.
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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.
Martin van Breems principal investigator
Martinus Van Breems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise poles in people with Movement Disorders and Aging, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
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 2 inclusion and 4 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 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
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 9 Apr 2009.