Physical ActivityNCT03218605
Which Physical Activity Influences Achilles Tendon Blood Flow the Most?
A study testing physical activity in people with Physical Activity, run by University Ghent at 1 site in Belgium.
Trial summary
Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Jan 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no history of Achilles tendon complaints
- healthy and active adolescents
Who cannot join
- history of Achilles tendon pain or current complaints
- not healthy or not active population
- children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Warming-up Activities on the Vascularisation of the Achilles Tendon: a Cohort Study
Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Therefore, knowledge about activities which increase blood flow in the AT could be useful in the development of a solid warming-up programme for the AT. The aim of this investigation was to define the influence of different kinds of physical activity on the vascularisation of the AT in a healthy asymptomatic population. Subjects performed five activities in randomized order: running, static stretch, dynamic stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before, immediately after, five and ten minutes after activity to investigate the duration of the vascular response to activity.
- Conditions
- Physical Activity
- Being tested
- physical activity
- Keywords
- Achilles tendon, Warming-up, Vascularisation, Physical activity, Oxygen-to-See (O2C)
- Medical subject headings
- Motor Activity, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
Subjects performed five activities: running, static stretch, dynamic stretch, cycling and rope skipping
| Study group | Role | What they receive |
|---|---|---|
| healthy active participants | Experimental | Not described Receives: Other: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Achilles tendon blood flow
measured with the non-invasive O2C device
Measured: 3 minutes before and immediately (0 minutes) after the physical activity to assess the change in blood flow due to the physical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startMar 2014
- Primary completionJan 2018
- Study completionJan 2018
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 Physical ActivityStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218605
- Sponsor's protocol ID
- 2013/401
- Status last verified
- Nov 2021
- First submitted
- 5 Jul 2017
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wezenbeek E, De Clercq D, Mahieu N, Willems T, Witvrouw E. Activity-Induced Increase in Achilles Tendon Blood Flow Is Age and Sex Dependent. Am J Sports Med. 2018 Sep;46(11):2678-2686. doi: 10.1177/0363546518786259. Epub 2018 Aug 1.
PubMed 30067065
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warming-up Activities on the Vascularisation of the Achilles Tendon: a Cohort Study
- ClinicalTrials.gov ID
- NCT03218605
- Acronym / sponsor ID
- 2013/401
- Conditions
- Physical Activity
- Keywords
- Achilles tendon, Warming-up, Vascularisation, Physical activity, Oxygen-to-See (O2C)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Therefore, knowledge about activities which increase blood flow in the AT could be useful in the development of a solid warming-up programme for the AT. The aim of this investigation was to define the influence of different kinds of physical activity on the vascularisation of the AT in a healthy asymptomatic population. Subjects performed five activities in randomized order: running, static stretch, dynamic stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before, immediately after, five and ten minutes after activity to investigate the duration of the vascular response to activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy active participants | Experimental | Other: physical activity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no history of Achilles tendon complaints
- healthy and active adolescents
Key exclusion criteria (3 listed)
- history of Achilles tendon pain or current complaints
- not healthy or not active population
- children
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 |
|---|---|---|
| physical activitySubjects performed five activities: running, static stretch, dynamic stretch, cycling and rope skipping | Other | healthy active participants |
Primary outcome
Change in Achilles tendon blood flow
Time frame: 3 minutes before and immediately (0 minutes) after the physical activity to assess the change in blood flow due to the physical activity
measured with the non-invasive O2C device
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 1 Dec 2021.
- Derived from this study: PubMed 30067065Wezenbeek E, De Clercq D, Mahieu N, Willems T, Witvrouw E. Activity-Induced Increase in Achilles Tendon Blood Flow Is Age and Sex Dependent. Am J Sports Med. 2018 Sep;46(11):2678-2686. doi: 10.1177/0363546518786259. Epub 2018 Aug 1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Physical Activity, run by University Ghent at 1 site in Belgium.
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 3 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 1 Dec 2021. 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 Belgium. 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?
Change in Achilles tendon blood flow (time frame: 3 minutes before and immediately (0 minutes) after the physical activity to assess the change in blood flow due to the physical activity). 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 NCT03218605, 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 1 Dec 2021.