TendinopathyMaLaGaNCT03853122
Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)
A study testing Best current practice exercise programme and Experimental exercise programme in people with Tendinopathy, run by University of Malaga.
Trial summary
This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Best current practice exercise programme and Experimental exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
- Pain duration for at least one month.
Who cannot join
- Corticosteroid injection in the studied tendon in the last 12 months;
- Other injuries in the affected lower limb in the last 12 months;
- Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
- Tendinous rupture history in the affected lower limb;
- Systemic diseases such as rheumatic arthritis or diabetes mellitus.
About this study
Official title: Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial
This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.
Read the detailed description
The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook \& Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.
Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.
- Conditions
- Tendinopathy
- Being tested
- Best current practice exercise programme, Experimental exercise programme
- Keywords
- tendinopathy, exercise, dosage, physiotherapy
- Medical subject headings
- Tendinopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best current practice exercise programmeOther
Also called Alfredson protocol, LEAP protocol
Therapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy).
Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises
Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise
Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads
Experimental exercise programmeOther
Also called MaLaGa protocol
Therapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests.
| Study group | Role | What they receive |
|---|---|---|
| Best current practice exercise programme | Active comparator | Therapeutic physical exercise, best current practice:
Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: two exercises performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).
Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: one exercise performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).
Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL, from daily to twice weekly, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). Receives: Other: Best current practice exercise programme |
| Experimental exercise programme | Experimental | Therapeutic physical exercise common for the three locations (Achilles, patellar and gluteal tendinopathy), based on an individual dosage and neuromuscular adaptations (five stages):
Strength training four exercises, once daily, three times/week, 14 weeks Aerobic training: Once daily, twice weekly Receives: Other: Experimental exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment (VISA) questionnaire POST
Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary outcomes (57)
Victorian Institute of Sport Assessment (VISA) questionnaire PRE
Visa-A model for Achilles tendon, Visa-P model for Patellar tendon, Visa-G model for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
Measured: Baseline, 1 week before start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM
Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
Measured: Short term, 7 weeks after start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up
Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
Measured: 52 weeks after the start of the intervention
Central Sensitization Inventory (CSI) PRE
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Measured: Baseline, 1 week before start of the intervention
Central Sensitization Inventory (CSI) SHORT TERM
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Measured: Short term, 7 weeks after start of the intervention
Central Sensitization Inventory (CSI) POST
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Central Sensitization Inventory (CSI) FOLLOW-UP
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Measured: 52 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Baseline, 1 week before start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Short term, 7 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: 52 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) PRE
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Measured: Baseline, 1 week before start of the intervention
Fear Avoidance Components Scale (FACS) SHORT TERM
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Measured: Short term, 7 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) POST
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Fear Avoidance Components Scale (FACS) FOLLOW-UP
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Measured: 52 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) PRE
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Measured: Baseline, 1 week before start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Measured: Short term, 7 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) POST
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Measured: 52 weeks after start of the intervention
Lower Limb Functional Index (LLFI) PRE
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Measured: Baseline, 1 week before start of the intervention
Lower Limb Functional Index (LLFI) POST
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower Limb Functional Index (LLFI) SHORT TERM
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Measured: Short term, 7 weeks after start of the intervention
Lower Limb Functional Index (LLFI) FOLLOW-UP
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Measured: 52 weeks after start of the intervention
Lower limb Strength PRE
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Measured: Short term, 7 weeks after start of the intervention
Lower limb Strength SHORT TERM
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Measured: Short term, 7 weeks after start of the intervention
Lower limb Strength POST
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower limb Strength FOLLOW-UP
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Measured: 52 weeks after start of the intervention
Muscular Thickness PRE
Measurement of the muscular thickness (in cm) by Ultrasonography
Measured: Baseline, 1 week before start of the intervention
Muscular Thickness SHORT TERM
Measurement of the muscular thickness (in cm) by Ultrasonography
Measured: Short term, 7 weeks after start of the intervention
Muscular Thickness POST
Measurement of the muscular thickness (in cm) by Ultrasonography
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Muscular Thickness FOLLOW-UP
Measurement of the muscular thickness (in cm) by Ultrasonography
Measured: 52 weeks after start of the intervention
Pressure Pain Threshold PRE
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Measured: Baseline, 1 week before start of the intervention
Pressure Pain Threshold SHORT TERM
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Measured: Short term, 7 weeks after start of the intervention
Pressure Pain Threshold POST
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Pressure Pain Threshold FOLLOW-UP
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Measured: 52 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) PRE
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Baseline, 1 week before start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Short term, 7 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) POST
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: 52 weeks after start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Baseline, 1 week before start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Short term, 7 weeks after start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) POST
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Measured: 52 weeks after start of the intervention
Treatment satisfaction PRE
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Measured: Baseline, 1 week before start of the intervention
Treatment satisfaction SHORT-TERM
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Measured: Short term, 7 weeks after start of the intervention
Treatment satisfaction POST
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Treatment satisfaction FOLLOW UP
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Measured: 52 weeks after start of the intervention
Lower limb Strength measured with hand-held dinamometer PRE
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Measured: Baseline, 1 week before start of the intervention
Lower limb Strength measured with hand-held dinamometer POST
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower limb Strength measured with hand-held dinamometer SHORT TERM
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Measured: Short term, 7 weeks after start of the intervention
Lower limb Strength measured with hand-held dinamometer FOLLOW UP
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Measured: 52 weeks after start of the intervention
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE
Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.
Measured: Baseline, 1 week before start of the intervention
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST
Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Measured: Baseline, 1 week before start of the intervention
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Measured: Short term, 7 weeks after start of the intervention
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Measured: Post, 14 weeks after start of the intervention (when intervention is finished)
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Measured: 52 weeks after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jun 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
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 TendinopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, with two parallel groups (control and intervention)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853122
- Sponsor's protocol ID
- DOSIS&TENDON
- Acronym
- MaLaGa
- Status last verified
- May 2023
- First submitted
- 11 Feb 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Escriche-Escuder A, Cuesta-Vargas AI, Casana J. Effect of a common exercise programme with an individualised progression criterion based on the measurement of neuromuscular capacity versus current best practice for lower limb tendinopathies (MaLaGa trial): a protocol for a randomised clinical trial. BMJ Open. 2021 Aug 17;11(8):e046729. doi: 10.1136/bmjopen-2020-046729.
PubMed 34404699
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03853122
- Acronym / sponsor ID
- MaLaGa / DOSIS&TENDON
- Conditions
- Tendinopathy
- Keywords
- tendinopathy, exercise, dosage, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Feb 2019 (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.
This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.
Detailed description
The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook \& Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.
Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with two parallel groups (control and intervention)
| Arm | Type | Receives |
|---|---|---|
| Best current practice exercise programme | Active comparator | Other: Best current practice exercise programmeTherapeutic physical exercise, best current practice: Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: two exercises performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: one exercise performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL, from daily to twice weekly, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). |
| Experimental exercise programme | Experimental | Other: Experimental exercise programmeTherapeutic physical exercise common for the three locations (Achilles, patellar and gluteal tendinopathy), based on an individual dosage and neuromuscular adaptations (five stages): Strength training four exercises, once daily, three times/week, 14 weeks Aerobic training: Once daily, twice weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
- Pain duration for at least one month.
Key exclusion criteria (5 listed)
- Corticosteroid injection in the studied tendon in the last 12 months;
- Other injuries in the affected lower limb in the last 12 months;
- Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
- Tendinous rupture history in the affected lower limb;
- Systemic diseases such as rheumatic arthritis or diabetes mellitus.
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 |
|---|---|---|
| Best current practice exercise programmeAlso: Alfredson protocol, LEAP protocolTherapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy). Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads | Other | Best current practice exercise programme |
| Experimental exercise programmeAlso: MaLaGa protocolTherapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests. | Other | Experimental exercise programme |
Primary outcome
Victorian Institute of Sport Assessment (VISA) questionnaire POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
57 secondary outcomes
Victorian Institute of Sport Assessment (VISA) questionnaire PRE
Time frame: Baseline, 1 week before start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM
Time frame: Short term, 7 weeks after start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up
Time frame: 52 weeks after the start of the intervention
Central Sensitization Inventory (CSI) PRE
Time frame: Baseline, 1 week before start of the intervention
Central Sensitization Inventory (CSI) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Central Sensitization Inventory (CSI) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Central Sensitization Inventory (CSI) FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE
Time frame: Baseline, 1 week before start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) PRE
Time frame: Baseline, 1 week before start of the intervention
Fear Avoidance Components Scale (FACS) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Fear Avoidance Components Scale (FACS) FOLLOW-UP
Time frame: 52 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) PRE
Time frame: Baseline, 1 week before start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Lower Limb Functional Index (LLFI) PRE
Time frame: Baseline, 1 week before start of the intervention
Lower Limb Functional Index (LLFI) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower Limb Functional Index (LLFI) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Lower Limb Functional Index (LLFI) FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Lower limb Strength PRE
Time frame: Short term, 7 weeks after start of the intervention
Lower limb Strength SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Lower limb Strength POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower limb Strength FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Muscular Thickness PRE
Time frame: Baseline, 1 week before start of the intervention
Muscular Thickness SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Muscular Thickness POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Muscular Thickness FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Pressure Pain Threshold PRE
Time frame: Baseline, 1 week before start of the intervention
Pressure Pain Threshold SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Pressure Pain Threshold POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Pressure Pain Threshold FOLLOW-UP
Time frame: 52 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) PRE
Time frame: Baseline, 1 week before start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM
Time frame: Short term, 7 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) POST
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP
Time frame: 52 weeks after start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE
Time frame: Baseline, 1 week before start of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 34404699Escriche-Escuder A, Cuesta-Vargas AI, Casana J. Effect of a common exercise programme with an individualised progression criterion based on the measurement of neuromuscular capacity versus current best practice for lower limb tendinopathies (MaLaGa trial): a protocol for a randomised clinical trial. BMJ Open. 2021 Aug 17;11(8):e046729. doi: 10.1136/bmjopen-2020-046729.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Best current practice exercise programme and Experimental exercise programme in people with Tendinopathy, run by University of Malaga.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Victorian Institute of Sport Assessment (VISA) questionnaire POST (time frame: Post, 14 weeks after start of the intervention (when intervention is finished)). 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 NCT03853122, 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 2023.