Adolescent Athletic PerformanceBFRNCT06684093
Effects of Back Squat Exercise with or Without Blood Flow Restriction in Healthy Adolescent Basketball Athletes
A study testing Back squat with Blood flow restriction machine and Back squats in people with Adolescent Athletic Performance and Muscle Strength Development, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to assess the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players aged 16-18. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Athletic Performance, Muscle Strength Development, Jump Height Improvement
- What is being tested?
- Back squat with Blood flow restriction machine and Back squats
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2024to 1 Jun 2024
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged between 16 and 18 years.
- Engaged in basketball training sessions at least three times per week.
- Competed in basketball within the last six months.
- No major injuries that limit their training session routines.
Who cannot join
- History or presence of cardiac, pulmonary, or metabolic conditions.
- Presence of vascular disorders in the upper or lower limbs.
- Individuals with coagulation disorders or those undergoing anticoagulant therapy.
- Recent surgeries or chronic conditions contraindicating Blood Flow Restriction (BFR) training.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Two sports academies in Lebanon (Mont la salle and Rebound academies)
Beirut
About this study
Official title: Effects of Back Squat Exercise with or Without Blood Flow Restriction in Healthy Adolescent Basketball Athletes: a Randomized Controlled Trial
The goal of this clinical trial is to assess the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players aged 16-18. The main questions it aims to answer are:
Does BFR training improve muscle strength more effectively than traditional high-intensity training? Does BFR training enhance jump height and ground reaction force (GRF) while reducing mechanical load? Researchers will compare BFR training to traditional high-intensity training to see if BFR training offers greater improvements in muscle strength, jump height, and GRF while potentially reducing knee joint stress.
Read more
Participants will:
Be randomly assigned to either the BFR training group or the high-intensity training group.
Undergo performance evaluations, including measurements of muscle strength, jump height, and GRF at three time points throughout the study.
Follow a training protocol specific to their assigned group
Read the detailed description
Detailed Description:
This randomized controlled study aims to evaluate the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players, focusing on performance enhancement and safety. The study was approved by the Committee Research Ethics of Saint Joseph University of Beirut (Code: 2023-325) on December 7, 2023.
Study Setting and Participants: The research was conducted within two sports academies in Lebanon, Mont La Salle and Rebound academies. A total of 50 adolescent basketball players, aged 16-18 years, participated. Inclusion criteria required regular training (at least three sessions per week) and competitive basketball experience within the last six months. Exclusion criteria included history or presence of cardiovascular, pulmonary, or metabolic conditions, vascular disorders, coagulation disorders, or ongoing anticoagulant therapy. Before starting the study, participants completed a recruitment questionnaire to gather demographic data and assess eligibility for BFR training.
Study Design and Randomization: Participants were randomly assigned into two groups:
Group 1 (BFR Training Group): Engaged in low-intensity resistance training (20-30% of 1RM) with BFR using pressure cuffs on the lower limbs.
Group 2 (High-Intensity Training Group): Engaged in traditional high-intensity resistance training (65-80% of 1RM) without BFR.
Both groups completed 12 sessions over six weeks, with a 48-hour interval between sessions. The study's structured approach allows for a comparison of the training modalities' effects on muscle strength, jump height, and ground reaction force (GRF).
Evaluation Protocol: Participants underwent baseline assessments before starting the exercise regimen. These assessments included occlusion pressure, 1-repetition maximum (1RM) testing, muscle strength, jump height, and GRF.
Occlusion Pressure Measurement: Measured using the VALD-performance system (Version 3 of the Airbands model, Australia) with athletes seated and cuffs placed proximally on the thigh (25% of the femur length).
1RM Testing: Participants performed warm-up sets before progressively increasing load until reaching the maximum weight they could lift with proper form.
Muscle Strength: Assessed using a digital dynamometer (KINVENT, K-PULL, France) for both quadriceps and hamstring muscles.
Jump Height and GRF: Evaluated using a force platform (KINVENT, France) during counter-movement jumps (CMJs).
Evaluations were conducted at three time points: baseline (M1), mid-intervention at three weeks (M2), and post-intervention at six weeks (M3). Each measurement was performed three times to ensure inter-rater reliability, with four physiotherapists maintaining consistency by evaluating the same athletes throughout the study.
Intervention Protocols:
Group 1 (BFR Training Group): Performed four sets of back squats at 20% of 1RM during weeks 1-3, increasing to 25% at week 3, and 30% during weeks 5-6.
Group 2 (High-Intensity Training Group): Began with 65% of 1RM in weeks 1-3, increasing to 70% at week 3, and 80% during weeks 5-6.
Both protocols aimed to progressively enhance strength while monitoring the effects on joint stress and overall performance.
Outcome Measures: The primary outcomes included changes in quadriceps and hamstring strength, jump height, and GRF over the intervention period. Secondary outcomes assessed knee joint stress and participant satisfaction with their respective training protocols.
Statistical Analysis: Data were analyzed using XLStat® software (AddinsoftR, Paris, France; version 2019.1.2). Descriptive statistics were calculated for demographic data. Mann-Whitney U tests were used for comparing groups, while Wilcoxon signed-rank tests evaluated within-group differences across time points (ΔM2-M1, ΔM3-M2, and ΔM3-M1). The reliability of measurements was assessed using the Intraclass Correlation Coefficient (ICC).
The study results are expected to provide insights into the effectiveness of BFR as a safer, low-load alternative to traditional high-intensity training in adolescent athletes, potentially offering a means to optimize performance while minimizing injury risk.
- Conditions
- Adolescent Athletic Performance, Muscle Strength Development, Jump Height Improvement, Ground Reaction Force (GRF) Enhancement, Injury Prevention in Sports, Blood Flow Restriction (BFR) Training Effects
- Being tested
- Back squat with Blood flow restriction machine, Back squats
- Keywords
- Blood Flow Restriction training, high intensity training, basketball, injury prevention, jump height, ground reaction force
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back squat with Blood flow restriction machineDevice
The blood flow restriction (BFR) machine is a specialized device designed to safely apply controlled pressure to the proximal limbs during exercise. It typically consists of adjustable cuffs or bands that are placed around the upper arms or thighs, which are connected to a pressure monitoring system. The device enables practitioners to restrict venous blood flow while allowing arterial blood flow to the working muscles. This method enhances the effects of low-intensity resistance training by promoting muscle hypertrophy and strength gains, similar to those achieved through high-intensity training. The BFR machine is commonly used in rehabilitation settings and athletic training programs to optimize performance and recovery while minimizing the risk of injury.
Back squatsBehavioural
Back squats without any blood flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Back Squat Exercise without Blood Flow Restriction | Active comparator | In this arm of the study, participants will perform back squat exercises without any blood flow restriction. This group serves as a control to evaluate the effects of traditional resistance training alone on strength and muscle development in healthy adolescent basketball athletes. Receives: Behavioral: Back squats |
| Back Squat Exercise with Blood Flow Restriction | Experimental | This arm of the study involves participants performing back squat exercises while blood flow restriction is applied to the upper legs. The aim is to assess the effects of combining traditional resistance training with blood flow restriction on strength and muscle hypertrophy in healthy adolescent basketball athletes. Receives: Device: Back squat with Blood flow restriction machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle strength (Kg)
Assessed using a digital dynamometer, this measure reflects the improvement in quadriceps strength, a key indicator of the effectiveness of low-intensity training with BFR.
Measured: Baseline (Day 0, before starting the protocol), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
Secondary outcomes (3)
Hamstring Muscle Strength (kg)
Evaluates the hamstring strength using a digital dynamometer to provide a broader view of muscle strength changes.
Measured: Baseline (Day 0, before starting the protocol), 3 weeks after the baseline assessment (Day 21), and 48 hours after the last session, approximately 6 weeks after the baseline assessment (Day 42).
Jump Height (cm)
Measures maximum jump height using a force platform to assess changes in lower limb explosive power.
Measured: Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
Ground reaction force (Newton)
Assesses the peak force generated during the landing phase of a countermovement jump using a force platform.
Measured: Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Athletic PerformanceStudies 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
- Model description
- The study uses a Parallel Assignment model where participants are randomly assigned to one of two intervention groups. Group 1: Blood Flow Restriction (BFR) Training Group - Participants engage in low-load resistance training (20-30% of 1-repetition maximum) with blood flow restriction applied to the working muscles using pressure cuffs. The training focuses on strengthening the quadriceps, hamstrings, and calf muscles. Group 2: Traditional High-Intensity Training Group - Participants perform high-intensity resistance exercises (70-85% of 1-repetition maximum) targeting the same muscle groups as the BFR group. Both groups undergo the respective training protocols three times a week over 8-12 weeks. Performance outcomes, including muscle strength, jump height, and ground reaction force (GRF), are measured at baseline, mid-intervention, and post-intervention. The parallel assignment allows a direct comparison of the effects of BFR training versus traditional high-intensity training on
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perla Mjaess, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684093
- Sponsor's protocol ID
- 2023-325
- Acronym
- BFR
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: In this study, the investigators plan to share the following specific individual participant data (IPD) upon completion of the trial: Demographic Information: Participants' age, gender, and baseline characteristics such as height, weight, and basketball experience. Intervention Details: Information regarding which intervention each participant received, specifically whether they performed back squat exercises with blood flow restriction or standard back squat exercises without restriction. Outcome Measures: Results for primary and secondary outcome measures, including: Muscle strength (1-repetition maximum testing results). Muscle hypertrophy (cross-sectional area measurements via ultrasound). Jump height Ground reaction force Adverse Events: Any recorded adverse events or side effects related to the interventions during the study period. Study Protocol Data: A summary of the study protocol, including the randomization process, assessment methods, and data collection procedures.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Back Squat Exercise with or Without Blood Flow Restriction in Healthy Adolescent Basketball Athletes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06684093
- Acronym / sponsor ID
- BFR / 2023-325
- Conditions
- Adolescent Athletic Performance, Muscle Strength Development, Jump Height Improvement, Ground Reaction Force (GRF) Enhancement, Injury Prevention in Sports, Blood Flow Restriction (BFR) Training Effects
- Keywords
- Blood Flow Restriction training, high intensity training, basketball, injury prevention, jump height, ground reaction force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 12 Nov 2024 (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 goal of this clinical trial is to assess the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players aged 16-18. The main questions it aims to answer are:
Does BFR training improve muscle strength more effectively than traditional high-intensity training? Does BFR training enhance jump height and ground reaction force (GRF) while reducing mechanical load? Researchers will compare BFR training to traditional high-intensity training to see if BFR training offers greater improvements in muscle strength, jump height, and GRF while potentially reducing knee joint stress.
Participants will:
Be randomly assigned to either the BFR training group or the high-intensity training group.
Undergo performance evaluations, including measurements of muscle strength, jump height, and GRF at three time points throughout the study.
Follow a training protocol specific to their assigned group
Detailed description
Detailed Description:
This randomized controlled study aims to evaluate the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players, focusing on performance enhancement and safety. The study was approved by the Committee Research Ethics of Saint Joseph University of Beirut (Code: 2023-325) on December 7, 2023.
Study Setting and Participants: The research was conducted within two sports academies in Lebanon, Mont La Salle and Rebound academies. A total of 50 adolescent basketball players, aged 16-18 years, participated. Inclusion criteria required regular training (at least three sessions per week) and competitive basketball experience within the last six months. Exclusion criteria included history or presence of cardiovascular, pulmonary, or metabolic conditions, vascular disorders, coagulation disorders, or ongoing anticoagulant therapy. Before starting the study, participants completed a recruitment questionnaire to gather demographic data and assess eligibility for BFR training.
Study Design and Randomization: Participants were randomly assigned into two groups:
Group 1 (BFR Training Group): Engaged in low-intensity resistance training (20-30% of 1RM) with BFR using pressure cuffs on the lower limbs.
Group 2 (High-Intensity Training Group): Engaged in traditional high-intensity resistance training (65-80% of 1RM) without BFR.
Both groups completed 12 sessions over six weeks, with a 48-hour interval between sessions. The study's structured approach allows for a comparison of the training modalities' effects on muscle strength, jump height, and ground reaction force (GRF).
Evaluation Protocol: Participants underwent baseline assessments before starting the exercise regimen. These assessments included occlusion pressure, 1-repetition maximum (1RM) testing, muscle strength, jump height, and GRF.
Occlusion Pressure Measurement: Measured using the VALD-performance system (Version 3 of the Airbands model, Australia) with athletes seated and cuffs placed proximally on the thigh (25% of the femur length).
1RM Testing: Participants performed warm-up sets before progressively increasing load until reaching the maximum weight they could lift with proper form.
Muscle Strength: Assessed using a digital dynamometer (KINVENT, K-PULL, France) for both quadriceps and hamstring muscles.
Jump Height and GRF: Evaluated using a force platform (KINVENT, France) during counter-movement jumps (CMJs).
Evaluations were conducted at three time points: baseline (M1), mid-intervention at three weeks (M2), and post-intervention at six weeks (M3). Each measurement was performed three times to ensure inter-rater reliability, with four physiotherapists maintaining consistency by evaluating the same athletes throughout the study.
Intervention Protocols:
Group 1 (BFR Training Group): Performed four sets of back squats at 20% of 1RM during weeks 1-3, increasing to 25% at week 3, and 30% during weeks 5-6.
Group 2 (High-Intensity Training Group): Began with 65% of 1RM in weeks 1-3, increasing to 70% at week 3, and 80% during weeks 5-6.
Both protocols aimed to progressively enhance strength while monitoring the effects on joint stress and overall performance.
Outcome Measures: The primary outcomes included changes in quadriceps and hamstring strength, jump height, and GRF over the intervention period. Secondary outcomes assessed knee joint stress and participant satisfaction with their respective training protocols.
Statistical Analysis: Data were analyzed using XLStat® software (AddinsoftR, Paris, France; version 2019.1.2). Descriptive statistics were calculated for demographic data. Mann-Whitney U tests were used for comparing groups, while Wilcoxon signed-rank tests evaluated within-group differences across time points (ΔM2-M1, ΔM3-M2, and ΔM3-M1). The reliability of measurements was assessed using the Intraclass Correlation Coefficient (ICC).
The study results are expected to provide insights into the effectiveness of BFR as a safer, low-load alternative to traditional high-intensity training in adolescent athletes, potentially offering a means to optimize performance while minimizing injury risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study uses a Parallel Assignment model where participants are randomly assigned to one of two intervention groups. Group 1: Blood Flow Restriction (BFR) Training Group - Participants engage in low-load resistance training (20-30% of 1-repetition maximum) with blood flow restriction applied to the working muscles using pressure cuffs. The training focuses on strengthening the quadriceps, hamstrings, and calf muscles. Group 2: Traditional High-Intensity Training Group - Participants perform high-intensity resistance exercises (70-85% of 1-repetition maximum) targeting the same muscle groups as the BFR group. Both groups undergo the respective training protocols three times a week over 8-12 weeks. Performance outcomes, including muscle strength, jump height, and ground reaction force (GRF), are measured at baseline, mid-intervention, and post-intervention. The parallel assignment allows a direct comparison of the effects of BFR training versus traditional high-intensity training on
| Arm | Type | Receives |
|---|---|---|
| Back Squat Exercise without Blood Flow Restriction | Active comparator | Behavioral: Back squatsIn this arm of the study, participants will perform back squat exercises without any blood flow restriction. This group serves as a control to evaluate the effects of traditional resistance training alone on strength and muscle development in healthy adolescent basketball athletes. |
| Back Squat Exercise with Blood Flow Restriction | Experimental | Device: Back squat with Blood flow restriction machineThis arm of the study involves participants performing back squat exercises while blood flow restriction is applied to the upper legs. The aim is to assess the effects of combining traditional resistance training with blood flow restriction on strength and muscle hypertrophy in healthy adolescent basketball athletes. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged between 16 and 18 years.
- Engaged in basketball training sessions at least three times per week.
- Competed in basketball within the last six months.
- No major injuries that limit their training session routines.
Key exclusion criteria (4 listed)
- History or presence of cardiac, pulmonary, or metabolic conditions.
- Presence of vascular disorders in the upper or lower limbs.
- Individuals with coagulation disorders or those undergoing anticoagulant therapy.
- Recent surgeries or chronic conditions contraindicating Blood Flow Restriction (BFR) training.
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 |
|---|---|---|
| Back squat with Blood flow restriction machineThe blood flow restriction (BFR) machine is a specialized device designed to safely apply controlled pressure to the proximal limbs during exercise. It typically consists of adjustable cuffs or bands that are placed around the upper arms or thighs, which are connected to a pressure monitoring system. The device enables practitioners to restrict venous blood flow while allowing arterial blood flow to the working muscles. This method enhances the effects of low-intensity resistance training by promoting muscle hypertrophy and strength gains, similar to those achieved through high-intensity training. The BFR machine is commonly used in rehabilitation settings and athletic training programs to optimize performance and recovery while minimizing the risk of injury. | Device | Back Squat Exercise with Blood Flow Restriction |
| Back squatsBack squats without any blood flow restriction | Behavioural | Back Squat Exercise without Blood Flow Restriction |
Primary outcome
Quadriceps Muscle strength (Kg)
Time frame: Baseline (Day 0, before starting the protocol), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
Assessed using a digital dynamometer, this measure reflects the improvement in quadriceps strength, a key indicator of the effectiveness of low-intensity training with BFR.
3 secondary outcomes
Hamstring Muscle Strength (kg)
Time frame: Baseline (Day 0, before starting the protocol), 3 weeks after the baseline assessment (Day 21), and 48 hours after the last session, approximately 6 weeks after the baseline assessment (Day 42).
Jump Height (cm)
Time frame: Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
Ground reaction force (Newton)
Time frame: Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes. In this study, the investigators plan to share the following specific individual participant data (IPD) upon completion of the trial: Demographic Information: Participants' age, gender, and baseline characteristics such as height, weight, and basketball experience. Intervention Details: Information regarding which intervention each participant received, specifically whether they performed back squat exercises with blood flow restriction or standard back squat exercises without restriction. Outcome Measures: Results for primary and secondary outcome measures, including: Muscle strength (1-repetition maximum testing results). Muscle hypertrophy (cross-sectional area measurements via ultrasound). Jump height Ground reaction force Adverse Events: Any recorded adverse events or side effects related to the interventions during the study period. Study Protocol Data: A summary of the study protocol, including the randomization process, assessment methods, and data collection procedures.
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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 Back squat with Blood flow restriction machine and Back squats in people with Adolescent Athletic Performance and Muscle Strength Development, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 4 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 12 Nov 2024. 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 Lebanon. 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?
Quadriceps Muscle strength (Kg) (time frame: Baseline (Day 0, before starting the protocol), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).). 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 12 Nov 2024.