Muscle WeaknessNCT03770442
Muscle Wasting in the Critically Ill
A study testing Cycling with FES and Routine physiotherapy in people with Muscle Weakness, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Muscle wasting is a common consequence of critical illness, and has a profound impact upon the rehabilitation of those who survive admission to critical to care. The investigators intend to assess if the application of 10 sessions over two weeks of passive cycling with electrical stimulation to the lower limbs and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Cycling with FES and Routine physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2019to 1 Nov 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be recruited in the Intensive Care Unit of the Royal Liverpool University Hospital. All patients will be over 18, and have a critical illness that requires mechanical ventilation with an initial period of sedation. This study will focus on patients with a definite or suspected case of sepsis from any source.
- Sepsis has been recently redefined as: "Life threatening organ-dysfunction caused by dysregulated host response to infection" whilst septic shock has become a subset of sepsis, defined as: "circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality(44).
- For the purposes of this study, a patient will be regarded as septic if they have evidence of infection-related organ failure (e.g. sepsis-associated coagulopathy, altered mental state, cardiovascular dysfunction, acute kidney injury, and altered liver function) and require invasive mechanical ventilation with either definite or suspected evidence of infection. This is to allow prompt treatment with FES rather than waiting for a positive microbiological result to be obtained.
- Within the definition of sepsis "from any source" a list of following is illustrative but not exhaustive:
- Urogenital sepsis (including urosepsis, pyelonephritis, endometritis and chorioamnionitis)
- Pneumonia (including community acquired, hospital acquired, and aspiration pneumonia. Ventilator associated pneumonia would be excluded.)
Show all 10Show fewer
- Neurological infections such as encephalitis and meningitis.
- Cellulitis, osteomyelitis and infections of soft tissue NOT affecting the lower limb.
- Surgical infections, including post-operative laparotomy with evidence of peritoneal soiling, and evidence of infection prior to the operation, in patients who require 2 or more organ system support after the operation.
- Intra-abdominal sepsis, including biliary sepsis, hepatitis, and acute pancreatitis. In the case of acute pancreatitis, evidence of infection is required to fulfil the criteria. Acute pancreatitis with sterile tissue/fluid samples would not be suitable.
Who cannot join
- Patients under 18
- Patients who decline consent
- Pregnancy
- Neuromuscular disease
- Rhabdomyolysis
- Lower limb trauma
Show all 11Show fewer
- Patients unlikely to survive to 96 hours post admission
- Consent unobtainable within 48 hours of admission
- Morbid obesity (BMI>40).
- Presence of a pacemaker or Implantable Cardiac Defibrillator (ICD).
- Unlikely to be mechanically ventilated for more than 48 hours.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Intensive Care Unit, Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: Effect of Early Rehabilitation Using an Active/Passive Cycling Device on Muscle Wasting in the Critically Ill: A Randomised Controlled Study
Muscle wasting is a common consequence of critical illness, and has a profound impact upon the rehabilitation of those who survive admission to critical to care. The investigators intend to assess if the application of 10 sessions over two weeks of passive cycling with electrical stimulation to the lower limbs and abdomen can prevent muscle loss, or at least cause less muscle loss, compared to patients who receive standard daily sessions of physiotherapy. This will be done by comparing the changes in muscle size on ultrasound between the two groups, comparing functional measures at a 3 month follow up, and by performing translational research using tissue samples taken during the study.
Read the detailed description
Patients are mechanically ventilated and sedated with a diagnosis of sepsis (from any source) will be eligible for this study. Provided they meet the inclusion criteria, they will be randomised within 48 hours of admission, to either ten 30 minute sessions of passive cycling with functional electrical stimulation (FES) to the thighs, hamstrings, calves and abdomen over a 14 day period, or to a control group of routine physiotherapy. The trial group will also receive this physiotherapy.
On admission to the study, all patients will receive on day 1:
Ultrasound measurements of:
Rectus femoris cross-sectional area Thickness of rectus femoris and vastus intermedius Thickness, pennation angle and derived fascicle length of vastus lateralis and medial head of gastrocnemius Thickness of rectus abdominis. Thickness of diaphragm
A blood sample taken from an arterial line A urine sample taken from a urinary catheter A muscle biopsy taken from the right vastus lateralis
They will then receive ten 30 minute sessions of passive cycling with functional electrical stimulation over 14 days, or a control group will receive routine physiotherapy during this period.
Repeat ultrasounds will be taken at days 3, 5, 7, 10 and 14. Repeat blood and urine sampling at days 5, 10 and 14. Repeat muscle biopsy at day 14.
All cycling, ultrasounds and tissue sampling will end on day 14 regardless of the ventilator status of the patient.
In patients who survive to be discharged from critical care, they will be followed up at 3 months for:
Repeat ultrasound scan of all muscles listed Six minute walk test Hand grip and lower limb dynamometry, Balance testing (by standing upright on a pressure plate for 20 seconds) Psychological assessment using the 36 item Short Form (SF-36) questionnaire
Tissue sampling will be stored in the University of Liverpool for analysis of biomarkers of muscle damage and loss between the two groups.
- Conditions
- Muscle Weakness
- Being tested
- Cycling with FES, Routine physiotherapy
- Keywords
- ICU acquired weakness (ICU-AW), FES, Functional Electrical Stimulation, Rehabilitation
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling with FESDevice
Also called RT-300 Supine, Restorative Therapies
As described already
Routine physiotherapyOther
As described already
| Study group | Role | What they receive |
|---|---|---|
| Cycling with FES | Experimental | Ten sessions of 14 days in patients consented within 48 hours of arriving in critical care who are sedated and mechanically ventilated with a diagnosis of sepsis from any source.
Sessions last a maximum of 30 minutes (with an ideal minimum of 20 minutes), using the Restorative Therapies (RT) 300 Supine with the Sage 12-channel stimulator. Stimulation will provided to the quadriceps, hamstrings, calves and abdomen. Both legs and both sides of the abdomen will be stimulated. Stimulation current settings are individualised for each patient and each muscle group.
These patients will also receive their routine physiotherapy that they would have received if they were in the control group (or not in the trial at all). Receives: Device: Cycling with FES |
| Control - routine physiotherapy | Active comparator | Usual daily physiotherapy, consisting of limb care and mobilisation, and respiratory care and exercises as appropriate. Receives: Other: Routine physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound assessment of rectus femoris - Change in cross sectional area (cm2)
Measurement of cross-sectional area of rectus femoris (cm2)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of rectus femoris - Change in muscle layer thickness (cm)
Measurement on muscle layer thickness of rectus femoris (cm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of anterior thigh musculature - Change in muscle layer thickness (cm)
Measurement of combined muscle layer thickness of rectus femoris and vastus intermedius (cm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of vastus lateralis - change in muscle layer thickness (cm)
Measurement of the thickness of the vastus lateralis between the superficial and deep aponeuroses (cm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of vastus lateralis - change in fascicle pennation angle (degrees)
Measurement of the pennation angle of the muscle fascicles as they insert into the deep aponeuroses of the vastus lateralis muscle (degrees)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of vastus lateralis - change in fascicle length (cm)
This is a single measure, derived by trigonometry (the Sine of the pennation angle multiplied by the muscle thickness).
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of the medial head of gastrocnemius - change in muscle thickness (cm)
Measurement of the thickness of the medial head of the gastrocnemius between the superficial and deep aponeuroses (cm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of the medial head of gastrocnemius - change in fascicle pennation angle (degrees)
Measurement of the pennation angle of the muscle fascicles as they insert into the deep aponeuroses of the medial head of gastrocnemius (angles)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of the medial head of gastrocnemius - change in fascicle length (cm)
This is single measure which is mathematically derived by trigonometry using the known pennation angle (degrees) and thickness (cm): the Sine of the pennation angle multiplied by the muscle thickness.
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of the rectus abdominis muscle - change in muscle layer thickness (cm)
Measurement of rectus abdominis muscle layer thickness - (cm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Diaphragm thickness assessment by ultrasound - change in end expiratory thickness (mm)
Assessment of thickness at end expiration (mm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Diaphragm thickness assessment by ultrasound - change in end inspiratory thickness (mm)
Assessment of thickness at end inspiration (mm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Diaphragm thickness assessment by ultrasound - change in thickening fraction (%)
Assessment of thickening fraction, derived mathematically from thicknesses at inspiration and expiration (%)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Ultrasound assessment of change in diaphragmatic excursion (cm)
Assessment of maximal excursion of diaphragm, measured with M-mode ultrasonography (mm)
Measured: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Secondary outcomes (20)
Measurement of change in blood biomarkers (microRNA analysis for markers of muscle loss, expressed as a percentage fold increase/decrease compared to baseline).
Blood samples taken during the study period and analysed for markers of muscle loss/degradation
Measured: Samples taken on days 1, 5, 10 and 14
Measurement of change in urinary biomarkers (microRNA analysis for markers of muscle loss, expressed as a percentage-fold increase/decrease compared to baseline).
Blood and urine samples taken during the study period and analysed for markers of muscle loss/degradation
Measured: Samples taken on days 1, 5, 10 and 14
Measurement of the number of biomarkers expressed from muscle biopsies (microRNA analysis for markers of muscle loss, expressed as the number and type of micro-RNAs expressed within the samples).
Muscle biopsy samples taken during the study period and analysed for markers of muscle loss/degradation. Number and type of micro-RNAs to be noted).
Measured: Samples taken on day 1 and 14
Measurement of muscle fibre cross sectional area from muscle biopsies (mm2)
Histological staining and analysis of muscle fibre composition, expressed in square millimetres and as a percentage-fold increase/decrease compared to baseline).
Measured: Samples taken on day 1 and 14
Follow up testing - Distance achieved in a 6 minute walk test, metres)
Distance achieved during a 6 minute shuttle walk of 20 metres length
Measured: At 3 month follow up
Follow up testing - Hand grip dynamometry (hand grip strength, Newtons)
Strength of hand grip in both hands
Measured: At 3 month follow up
Follow up - Lower limb strength assessment - Force generated at maximal contraction for knee extension (Newtons)
Strength of extension at the knee in both legs using a hand held dynamometry device (microFET 2 wireless device). Measured in Newtons.
Measured: At 3 month follow up
Follow up testing - Balance assessment - Comparison of changes in center of pressure on a pressure plate.
Comparison of changes in centre of pressure on a pressure plate. The centre of pressure is measured over 20 seconds with the participant standing still. Maximal variation in lateral and anterior-posterior sway is recorded by the pressure plate.
Measured: At 3 month follow up
Follow up testing - Psychological assessment - Comparison of total scores obtained from the SF-36 questionnaire (maximum score 100, minimum score zero).
Comparison of scores obtained from the SF-36 questionnaire between the two groups. A lower score indicates greater disability.
Measured: At 3 month follow up
Follow Up - Maximal Inspiratory Pressure monitoring in kilopascals (kPa)
Using the Power Breathe K2 device
Measured: At 3 month follow up
Incidence of delirium during the trial period - using the CAM-ICU tool.
Assessed by twice daily Cambridge Assessment Method for the ICU (CAM-ICU) assessments
Measured: Days 1-14
Incidence of renal replacement therapy during the trial period
Daily monitoring to see if patient has required renal replacement therapy (defined as either haemofiltration or haemodialysis).
Measured: Days 1-14
Total dose of noradrenaline given per day
Daily monitoring of doses of inotropic and vasopressor drugs
Measured: Day 1-14
Overall fluid balance (in mls) at the end of each study day
Daily noting of 24 hour fluid balance
Measured: Day 1-14
Total Insulin doses (in international units) required per day
Daily monitoring of exogenous insulin requirements
Measured: Day 1-14
Blood glucose concentration (mmol/L)
Daily monitoring of glucose levels
Measured: Day 1-14
Heart rate variability
Measured via a wireless skin patch
Measured: Days 1 - 14 but only on the days where cycling takes place (ten sessions)
Safety - number of times an endotracheal/tracheostomy tube is dislodged during the cycling sessions
Expressed as a simple count of how many times an airway device dislodges
Measured: Days 1 - 14 but only on the days where cycling takes place (ten sessions)
Safety - number of times an nasogastric tube is dislodged during the cycling sessions
Expressed as a simple count of how many times a nasogastric feed tube dislodges.
Measured: Days 1 - 14 but only on the days where cycling takes place (ten sessions).
Safety - number of times an a central or arterial line device is dislodged during the cycling sessions
Expressed as a simple count of how many times a central or arterial line dislodges.
Measured: Days 1 - 14 but only on the days where cycling takes place (ten sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start14 Jan 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingeborg Welters, University of Liverpool
- Investigators
- Ingeborg D Welters, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770442
- Sponsor's protocol ID
- UoL001367
- Status last verified
- Nov 2020
- First submitted
- 15 Oct 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Translational research will take place in the Institute of Aging and Chronic Disease. Only the participant number of the sample will be shared with any staff working with tissue samples.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Rehabilitation Using an Active/Passive Cycling Device on Muscle Wasting in the Critically Ill: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03770442
- Acronym / sponsor ID
- UoL001367
- Conditions
- Muscle Weakness
- Keywords
- ICU acquired weakness (ICU-AW), FES, Functional Electrical Stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 10 Dec 2018 (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.
Muscle wasting is a common consequence of critical illness, and has a profound impact upon the rehabilitation of those who survive admission to critical to care. The investigators intend to assess if the application of 10 sessions over two weeks of passive cycling with electrical stimulation to the lower limbs and abdomen can prevent muscle loss, or at least cause less muscle loss, compared to patients who receive standard daily sessions of physiotherapy. This will be done by comparing the changes in muscle size on ultrasound between the two groups, comparing functional measures at a 3 month follow up, and by performing translational research using tissue samples taken during the study.
Detailed description
Patients are mechanically ventilated and sedated with a diagnosis of sepsis (from any source) will be eligible for this study. Provided they meet the inclusion criteria, they will be randomised within 48 hours of admission, to either ten 30 minute sessions of passive cycling with functional electrical stimulation (FES) to the thighs, hamstrings, calves and abdomen over a 14 day period, or to a control group of routine physiotherapy. The trial group will also receive this physiotherapy.
On admission to the study, all patients will receive on day 1:
Ultrasound measurements of:
Rectus femoris cross-sectional area Thickness of rectus femoris and vastus intermedius Thickness, pennation angle and derived fascicle length of vastus lateralis and medial head of gastrocnemius Thickness of rectus abdominis. Thickness of diaphragm
A blood sample taken from an arterial line A urine sample taken from a urinary catheter A muscle biopsy taken from the right vastus lateralis
They will then receive ten 30 minute sessions of passive cycling with functional electrical stimulation over 14 days, or a control group will receive routine physiotherapy during this period.
Repeat ultrasounds will be taken at days 3, 5, 7, 10 and 14. Repeat blood and urine sampling at days 5, 10 and 14. Repeat muscle biopsy at day 14.
All cycling, ultrasounds and tissue sampling will end on day 14 regardless of the ventilator status of the patient.
In patients who survive to be discharged from critical care, they will be followed up at 3 months for:
Repeat ultrasound scan of all muscles listed Six minute walk test Hand grip and lower limb dynamometry, Balance testing (by standing upright on a pressure plate for 20 seconds) Psychological assessment using the 36 item Short Form (SF-36) questionnaire
Tissue sampling will be stored in the University of Liverpool for analysis of biomarkers of muscle damage and loss between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling with FES | Experimental | Device: Cycling with FESTen sessions of 14 days in patients consented within 48 hours of arriving in critical care who are sedated and mechanically ventilated with a diagnosis of sepsis from any source. Sessions last a maximum of 30 minutes (with an ideal minimum of 20 minutes), using the Restorative Therapies (RT) 300 Supine with the Sage 12-channel stimulator. Stimulation will provided to the quadriceps, hamstrings, calves and abdomen. Both legs and both sides of the abdomen will be stimulated. Stimulation current settings are individualised for each patient and each muscle group. These patients will also receive their routine physiotherapy that they would have received if they were in the control group (or not in the trial at all). |
| Control - routine physiotherapy | Active comparator | Other: Routine physiotherapyUsual daily physiotherapy, consisting of limb care and mobilisation, and respiratory care and exercises as appropriate. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients will be recruited in the Intensive Care Unit of the Royal Liverpool University Hospital. All patients will be over 18, and have a critical illness that requires mechanical ventilation with an initial period of sedation. This study will focus on patients with a definite or suspected case of sepsis from any source.
- Sepsis has been recently redefined as: "Life threatening organ-dysfunction caused by dysregulated host response to infection" whilst septic shock has become a subset of sepsis, defined as: "circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality(44).
- For the purposes of this study, a patient will be regarded as septic if they have evidence of infection-related organ failure (e.g. sepsis-associated coagulopathy, altered mental state, cardiovascular dysfunction, acute kidney injury, and altered liver function) and require invasive mechanical ventilation with either definite or suspected evidence of infection. This is to allow prompt treatment with FES rather than waiting for a positive microbiological result to be obtained.
- Within the definition of sepsis "from any source" a list of following is illustrative but not exhaustive:
- Urogenital sepsis (including urosepsis, pyelonephritis, endometritis and chorioamnionitis)
Key exclusion criteria (11 listed)
- Patients under 18
- Patients who decline consent
- Pregnancy
- Neuromuscular disease
- Rhabdomyolysis
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 |
|---|---|---|
| Cycling with FESAlso: RT-300 Supine, Restorative TherapiesAs described already | Device | Cycling with FES |
| Routine physiotherapyAs described already | Other | Control - routine physiotherapy |
Primary outcome
Ultrasound assessment of rectus femoris - Change in cross sectional area (cm2)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of cross-sectional area of rectus femoris (cm2)
Ultrasound assessment of rectus femoris - Change in muscle layer thickness (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement on muscle layer thickness of rectus femoris (cm)
Ultrasound assessment of anterior thigh musculature - Change in muscle layer thickness (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of combined muscle layer thickness of rectus femoris and vastus intermedius (cm)
Ultrasound assessment of vastus lateralis - change in muscle layer thickness (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of the thickness of the vastus lateralis between the superficial and deep aponeuroses (cm)
Ultrasound assessment of vastus lateralis - change in fascicle pennation angle (degrees)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of the pennation angle of the muscle fascicles as they insert into the deep aponeuroses of the vastus lateralis muscle (degrees)
Ultrasound assessment of vastus lateralis - change in fascicle length (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
This is a single measure, derived by trigonometry (the Sine of the pennation angle multiplied by the muscle thickness).
Ultrasound assessment of the medial head of gastrocnemius - change in muscle thickness (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of the thickness of the medial head of the gastrocnemius between the superficial and deep aponeuroses (cm)
Ultrasound assessment of the medial head of gastrocnemius - change in fascicle pennation angle (degrees)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of the pennation angle of the muscle fascicles as they insert into the deep aponeuroses of the medial head of gastrocnemius (angles)
Ultrasound assessment of the medial head of gastrocnemius - change in fascicle length (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
This is single measure which is mathematically derived by trigonometry using the known pennation angle (degrees) and thickness (cm): the Sine of the pennation angle multiplied by the muscle thickness.
Ultrasound assessment of the rectus abdominis muscle - change in muscle layer thickness (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Measurement of rectus abdominis muscle layer thickness - (cm)
Diaphragm thickness assessment by ultrasound - change in end expiratory thickness (mm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Assessment of thickness at end expiration (mm)
Diaphragm thickness assessment by ultrasound - change in end inspiratory thickness (mm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Assessment of thickness at end inspiration (mm)
Diaphragm thickness assessment by ultrasound - change in thickening fraction (%)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Assessment of thickening fraction, derived mathematically from thicknesses at inspiration and expiration (%)
Ultrasound assessment of change in diaphragmatic excursion (cm)
Time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.
Assessment of maximal excursion of diaphragm, measured with M-mode ultrasonography (mm)
20 secondary outcomes
Measurement of change in blood biomarkers (microRNA analysis for markers of muscle loss, expressed as a percentage fold increase/decrease compared to baseline).
Time frame: Samples taken on days 1, 5, 10 and 14
Measurement of change in urinary biomarkers (microRNA analysis for markers of muscle loss, expressed as a percentage-fold increase/decrease compared to baseline).
Time frame: Samples taken on days 1, 5, 10 and 14
Measurement of the number of biomarkers expressed from muscle biopsies (microRNA analysis for markers of muscle loss, expressed as the number and type of micro-RNAs expressed within the samples).
Time frame: Samples taken on day 1 and 14
Measurement of muscle fibre cross sectional area from muscle biopsies (mm2)
Time frame: Samples taken on day 1 and 14
Follow up testing - Distance achieved in a 6 minute walk test, metres)
Time frame: At 3 month follow up
Follow up testing - Hand grip dynamometry (hand grip strength, Newtons)
Time frame: At 3 month follow up
Follow up - Lower limb strength assessment - Force generated at maximal contraction for knee extension (Newtons)
Time frame: At 3 month follow up
Follow up testing - Balance assessment - Comparison of changes in center of pressure on a pressure plate.
Time frame: At 3 month follow up
Follow up testing - Psychological assessment - Comparison of total scores obtained from the SF-36 questionnaire (maximum score 100, minimum score zero).
Time frame: At 3 month follow up
Follow Up - Maximal Inspiratory Pressure monitoring in kilopascals (kPa)
Time frame: At 3 month follow up
Incidence of delirium during the trial period - using the CAM-ICU tool.
Time frame: Days 1-14
Incidence of renal replacement therapy during the trial period
Time frame: Days 1-14
Total dose of noradrenaline given per day
Time frame: Day 1-14
Overall fluid balance (in mls) at the end of each study day
Time frame: Day 1-14
Total Insulin doses (in international units) required per day
Time frame: Day 1-14
Blood glucose concentration (mmol/L)
Time frame: Day 1-14
Heart rate variability
Time frame: Days 1 - 14 but only on the days where cycling takes place (ten sessions)
Safety - number of times an endotracheal/tracheostomy tube is dislodged during the cycling sessions
Time frame: Days 1 - 14 but only on the days where cycling takes place (ten sessions)
Safety - number of times an nasogastric tube is dislodged during the cycling sessions
Time frame: Days 1 - 14 but only on the days where cycling takes place (ten sessions).
Safety - number of times an a central or arterial line device is dislodged during the cycling sessions
Time frame: Days 1 - 14 but only on the days where cycling takes place (ten sessions).
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 4 Nov 2020.
- Individual participant dataSharing planned: No. Translational research will take place in the Institute of Aging and Chronic Disease. Only the participant number of the sample will be shared with any staff working with tissue samples.
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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.
Ingeborg D Welters principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling with FES and Routine physiotherapy in people with Muscle Weakness, run by University of Liverpool at 1 site in United Kingdom.
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 10 inclusion and 11 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 4 Nov 2020. 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 Kingdom. 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?
Ultrasound assessment of rectus femoris - Change in cross sectional area (cm2) (time frame: Ultrasounds taken on day 1, 3, 5, 7, 10 and 14, and at 3 month follow up.). The study lists 14 primary outcomes in all. 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 4 Nov 2020.