AgingNCT01574794
Exercise Intervention and Running Biomechanics in Older Adults
A study testing Muscle strengthening exercises and Muscle stretching exercise in people with Aging and Physical Activity, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this study is to understand the effects of muscle strengthening and stretching exercise intervention on isometric muscle strength, joint flexibility and running biomechanical patterns in older recreational runners. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Activity
- What is being tested?
- Muscle strengthening exercises and Muscle stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Sep 2013
- Phase
- Interventional
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no injuries of the lower extremity within 3 months prior to participation
- running recreationally 2-3 times/week
- familiar and comfortable with treadmill running
- in good health upon entry into the study
- no use of orthotics in the shoe
Who cannot join
- lower extremity injury within the last 3 months
- surgery to the lower extremity within the last 8 months
- head injury/vestibular disorder within the last 6 months
- inability to speak or read English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Running Gait Biomechanics Following an Intervention Program in Older Runners
The goal of this study is to understand the effects of muscle strengthening and stretching exercise intervention on isometric muscle strength, joint flexibility and running biomechanical patterns in older recreational runners. To do so, the subjects will be assessed before and after they engage in a 8-week exercise intervention program.
- Conditions
- Aging, Physical Activity
- Being tested
- Muscle strengthening exercises, Muscle stretching exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strengthening exercisesOther
The group will perform 8-week home based muscle strengthening exercises with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist.
Muscle stretching exerciseOther
The group will perform 8 week home based exercise intervention with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist
| Study group | Role | What they receive |
|---|---|---|
| Strengthening Exercises | Experimental | Recreational older runners recruited from local community Receives: Other: Muscle strengthening exercises |
| Stretching Exercises | Experimental | Recreational older runners recruited from local community Receives: Other: Muscle stretching exercise |
| Control Group | No intervention | Recreational older runners recruited from local community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of biomechanical movement patterns
Biomechanical measurements (kinematics and kinetics) will be taken at baseline and at 8 weeks of intervention.
Measured: 8 weeks
Secondary outcomes (1)
Changes in isometric muscle strength and joint flexibility
Measurements of isometric muscle strength and joint flexibility will be taken at baseline and at 8 weeks of intervention program.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Running Injury Clinic, Alberta Heritage Foundation for Medical Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Reginaldo Fukuchi, MSc, University of Calgary
- Investigators
- Reed Ferber, PhD, Principal investigator, Running Injury Clinic, Faculty of Kinesiology, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574794
- Sponsor's protocol ID
- RIC-CAPES-001
- Status last verified
- Dec 2014
- First submitted
- 6 Apr 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Running Gait Biomechanics Following an Intervention Program in Older Runners
- ClinicalTrials.gov ID
- NCT01574794
- Acronym / sponsor ID
- RIC-CAPES-001
- Conditions
- Aging, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Running Injury Clinic, Alberta Heritage Foundation for Medical Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Apr 2012 (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 goal of this study is to understand the effects of muscle strengthening and stretching exercise intervention on isometric muscle strength, joint flexibility and running biomechanical patterns in older recreational runners. To do so, the subjects will be assessed before and after they engage in a 8-week exercise intervention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening Exercises | Experimental | Other: Muscle strengthening exercisesRecreational older runners recruited from local community |
| Stretching Exercises | Experimental | Other: Muscle stretching exerciseRecreational older runners recruited from local community |
| Control Group | No intervention | –Recreational older runners recruited from local community |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- no injuries of the lower extremity within 3 months prior to participation
- running recreationally 2-3 times/week
- familiar and comfortable with treadmill running
- in good health upon entry into the study
- no use of orthotics in the shoe
Key exclusion criteria (4 listed)
- lower extremity injury within the last 3 months
- surgery to the lower extremity within the last 8 months
- head injury/vestibular disorder within the last 6 months
- inability to speak or read English.
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 |
|---|---|---|
| Muscle strengthening exercisesThe group will perform 8-week home based muscle strengthening exercises with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist. | Other | Strengthening Exercises |
| Muscle stretching exerciseThe group will perform 8 week home based exercise intervention with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist | Other | Stretching Exercises |
Primary outcome
Changes from baseline of biomechanical movement patterns
Time frame: 8 weeks
Biomechanical measurements (kinematics and kinetics) will be taken at baseline and at 8 weeks of intervention.
1 secondary outcome
Changes in isometric muscle strength and joint flexibility
Time frame: 8 weeks
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 3 Dec 2014.
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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.
Reed Ferber, PhD principal investigator
Running Injury Clinic, Faculty of Kinesiology, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strengthening exercises and Muscle stretching exercise in people with Aging and Physical Activity, run by University of Calgary at 1 site 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 5 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 3 Dec 2014. 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 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.
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?
Changes from baseline of biomechanical movement patterns (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
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 3 Dec 2014.