Immobilization, TonicNCT03054376
Vascular Health With Immobilization and Exercise Training
A study testing Immobilization, Training with non immobilized leg and Exercise training with both legs in people with Immobilization, Tonic and Physical Activity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study includes healthy young habitually active subjects. All subjects are subjected to two weeks of immobilization of one leg followed by four weeks of training of both legs. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Immobilization, Tonic, Physical Activity
- What is being tested?
- Immobilization, Training with non immobilized leg and Exercise training with both legs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2017to 20 Oct 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI <25
- Habitually/moderately physically active
Who cannot join
- Known chronic medical disorder
- Smoking
- Excessive alcohol intake
- Known genetic/familial predisposition for thrombosis
- Hormonal birth control
- High level strength or endurance training on a regular basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization
The study includes healthy young habitually active subjects. All subjects are subjected to two weeks of immobilization of one leg followed by four weeks of training of both legs. The subjects are randomized to either one-leg training of the non-immobilized leg during the two-week immobilization period or to no training of the non-immobilized leg during the immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis and apoptosis, muscle metabolic markers, vascular function, vascular proteins and performance.
Read the detailed description
One leg of young healthy subjects will be immoblized for two weeks. Changes in angiogenic proteins and markers of apoptosis in muscle tissue and muscle extracellular fluid will be determined in both legs and in parallel the functional consequences of immobilization will be assessed. Vascular function and vascular proteins will also be determined. In order to understand how the oxidative capacity of the muscle is altered in parallel with changes in capillarization, markers of mitochondria will be measured .Half of the subjects will be randomized to single-leg training during the immobilization period to assess whether simultaneous training reduces the loss of capillaries, muscle function and vascular function in the immobilized leg. After the immobilization period the study participants will train the immobilized leg and the control leg for four weeks by moderate to intense interval cycle training and the same parameteres as during immobilization will be assessed in both legs. The study will also include measurements of circulating compounds and platelets in blood.
- Conditions
- Immobilization, Tonic, Physical Activity
- Being tested
- Immobilization, Training with non immobilized leg, Exercise training with both legs
- Keywords
- Immobilization, Angiogenesis, Skeletal muscle, Exercise training, Vascular function
- Medical subject headings
- Immobility Response, Tonic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmobilizationOther
Full length cast of one leg R/L randomized
Training with non immobilized legOther
Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks
Exercise training with both legsOther
Exercise training will be conducted regularly on a cycle ergometer during a four week period
| Study group | Role | What they receive |
|---|---|---|
| Immobilization | Active comparator | After baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will not be trained. After the two weeks the subjects will train both legs for four weeks. Receives: Other: Immobilization; Other: Exercise training with both legs |
| Training of non-immobilized leg | Active comparator | After baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will be trained. After the two weeks the subjects will train both legs for four weeks. Receives: Other: Immobilization; Other: Training with non immobilized leg; Other: Exercise training with both legs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiogenesis
Skeletal muscle capillarization-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization
Vascular function
Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization
Angiogenesis
Skeletal muscle capillarization-comparison between legs
Measured: Change from after immobilization to after 4 weeks of training
Vascular function
Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs
Measured: Change from after immobilization to after 4 weeks of training
Secondary outcomes (9)
Vascular and metabolic proteins
Proteins of importance for vascular function and muscle metabolism measured in muscle biopsy samples, skeletal muscle interstitial fluid and plasma-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Arterial blood pressure
Measured by sphygmomanometer and intra-arterially
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Knee extensor performance
Measurements of maximal power and endurance-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Maximal oxygen uptake
Measured by gas analysis during an incremental ergometer cycle protocol
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Body composition
Measurements by dual energy x-ray absorptiometry
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Skin microcirculation
Measurements of skin blood flow and morphology and relevant proteins in skin biopsies
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Markers of bone metabolism
Measurements of bone markers in plasma
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Markers of angiogenesis
Measurement of angiogenic and apoptotic factors-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Vascular function-non-invasive
Measurements of skeletal muscle blood flow at rest, during passive movement, during exercise, after five min of occlusion and during infusion of vasodilators and constrictors-comparison between legs
Measured: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start15 Mar 2017
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
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 Immobilization, TonicStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, University of Leeds, Liverpool John Moores University, Radboud University Medical Center
- Responsible party
- Principal investigator, Ylva Hellsten, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054376
- Sponsor's protocol ID
- ANG-CV- IMMOB
- Status last verified
- Nov 2022
- First submitted
- 5 Feb 2017
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gliemann L, Rytter N, Jorgensen TS, Piil P, Carter H, Nyberg M, Grassi M, Daumer M, Hellsten Y. The Impact of Lower Limb Immobilization and Rehabilitation on Angiogenic Proteins and Capillarization in Skeletal Muscle. Med Sci Sports Exerc. 2021 Sep 1;53(9):1797-1806. doi: 10.1249/MSS.0000000000002665.
PubMed 33787530
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization
- ClinicalTrials.gov ID
- NCT03054376
- Acronym / sponsor ID
- ANG-CV- IMMOB
- Conditions
- Immobilization, Tonic, Physical Activity
- Keywords
- Immobilization, Angiogenesis, Skeletal muscle, Exercise training, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, University of Leeds, Liverpool John Moores University, Radboud University Medical Center
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 15 Feb 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.
The study includes healthy young habitually active subjects. All subjects are subjected to two weeks of immobilization of one leg followed by four weeks of training of both legs. The subjects are randomized to either one-leg training of the non-immobilized leg during the two-week immobilization period or to no training of the non-immobilized leg during the immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis and apoptosis, muscle metabolic markers, vascular function, vascular proteins and performance.
Detailed description
One leg of young healthy subjects will be immoblized for two weeks. Changes in angiogenic proteins and markers of apoptosis in muscle tissue and muscle extracellular fluid will be determined in both legs and in parallel the functional consequences of immobilization will be assessed. Vascular function and vascular proteins will also be determined. In order to understand how the oxidative capacity of the muscle is altered in parallel with changes in capillarization, markers of mitochondria will be measured .Half of the subjects will be randomized to single-leg training during the immobilization period to assess whether simultaneous training reduces the loss of capillaries, muscle function and vascular function in the immobilized leg. After the immobilization period the study participants will train the immobilized leg and the control leg for four weeks by moderate to intense interval cycle training and the same parameteres as during immobilization will be assessed in both legs. The study will also include measurements of circulating compounds and platelets in blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
| Arm | Type | Receives |
|---|---|---|
| Immobilization | Active comparator | Other: Immobilization, Other: Exercise training with both legsAfter baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will not be trained. After the two weeks the subjects will train both legs for four weeks. |
| Training of non-immobilized leg | Active comparator | Other: Immobilization, Other: Training with non immobilized leg, Other: Exercise training with both legsAfter baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will be trained. After the two weeks the subjects will train both legs for four weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- BMI <25
- Habitually/moderately physically active
Key exclusion criteria (6 listed)
- Known chronic medical disorder
- Smoking
- Excessive alcohol intake
- Known genetic/familial predisposition for thrombosis
- Hormonal birth control
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 |
|---|---|---|
| ImmobilizationFull length cast of one leg R/L randomized | Other | Immobilization, Training of non-immobilized leg |
| Training with non immobilized legExercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks | Other | Training of non-immobilized leg |
| Exercise training with both legsExercise training will be conducted regularly on a cycle ergometer during a four week period | Other | Immobilization, Training of non-immobilized leg |
Primary outcome
Angiogenesis
Time frame: Change from baseline to after 2 weeks of immobilization
Skeletal muscle capillarization-comparison between legs
Vascular function
Time frame: Change from baseline to after 2 weeks of immobilization
Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs
Angiogenesis
Time frame: Change from after immobilization to after 4 weeks of training
Skeletal muscle capillarization-comparison between legs
Vascular function
Time frame: Change from after immobilization to after 4 weeks of training
Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs
9 secondary outcomes
Vascular and metabolic proteins
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Arterial blood pressure
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Knee extensor performance
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Maximal oxygen uptake
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Body composition
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Skin microcirculation
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Markers of bone metabolism
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Markers of angiogenesis
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Vascular function-non-invasive
Time frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
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 Nov 2022.
- Derived from this study: PubMed 33787530Gliemann L, Rytter N, Jorgensen TS, Piil P, Carter H, Nyberg M, Grassi M, Daumer M, Hellsten Y. The Impact of Lower Limb Immobilization and Rehabilitation on Angiogenic Proteins and Capillarization in Skeletal Muscle. Med Sci Sports Exerc. 2021 Sep 1;53(9):1797-1806. doi: 10.1249/MSS.0000000000002665.
- Individual participant dataSharing planned: No
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 Immobilization, Training with non immobilized leg and Exercise training with both legs in people with Immobilization, Tonic and Physical Activity, run by University of Copenhagen at 1 site in Denmark.
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 Nov 2022. 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 Denmark. 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?
Angiogenesis (time frame: Change from baseline to after 2 weeks of immobilization). The study lists 4 primary outcomes in all. 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 NCT03054376, 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 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.