- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853122
Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial) (MaLaGa)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Best current practice exercise programme
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). |
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
Other Names:
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Experimental: Experimental exercise programme
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 |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Post, 14 weeks after start of the intervention (when intervention is finished)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Victorian Institute of Sport Assessment (VISA) questionnaire PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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).
|
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
|
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).
|
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
|
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).
|
52 weeks after the start of the intervention
|
Central Sensitization Inventory (CSI) PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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)
|
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
|
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)
|
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)
|
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)
|
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
|
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)
|
52 weeks after start of the intervention
|
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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
|
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
|
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
|
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)
|
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
|
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
|
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
|
52 weeks after start of the intervention
|
Fear Avoidance Components Scale (FACS) PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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.
|
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
|
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.
|
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)
|
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.
|
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
|
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.
|
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
|
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..."
|
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
|
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..."
|
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)
|
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..."
|
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
|
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..."
|
52 weeks after start of the intervention
|
Lower Limb Functional Index (LLFI) PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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).
|
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)
|
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).
|
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
|
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).
|
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
|
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).
|
52 weeks after start of the intervention
|
Lower limb Strength PRE
Time Frame: Short term, 7 weeks after start of the intervention
|
Assessment of the isometric strength in the leg press machine using a s-beam load cell
|
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
|
Assessment of the isometric strength in the leg press machine using a s-beam load cell
|
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)
|
Assessment of the isometric strength in the leg press machine using a s-beam load cell
|
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
|
Assessment of the isometric strength in the leg press machine using a s-beam load cell
|
52 weeks after start of the intervention
|
Muscular Thickness PRE
Time Frame: Baseline, 1 week before start of the intervention
|
Measurement of the muscular thickness (in cm) by Ultrasonography
|
Baseline, 1 week before start of the intervention
|
Muscular Thickness SHORT TERM
Time Frame: Short term, 7 weeks after start of the intervention
|
Measurement of the muscular thickness (in cm) by Ultrasonography
|
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)
|
Measurement of the muscular thickness (in cm) by Ultrasonography
|
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
|
Measurement of the muscular thickness (in cm) by Ultrasonography
|
52 weeks after start of the intervention
|
Pressure Pain Threshold PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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.
|
Baseline, 1 week before start of the intervention
|
Pressure Pain Threshold SHORT TERM
Time Frame: Short term, 7 weeks after start of the intervention
|
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.
|
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)
|
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.
|
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
|
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.
|
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
|
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
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
|
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
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)
|
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
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
|
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
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
|
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
Baseline, 1 week before start of the intervention
|
Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM
Time Frame: Short term, 7 weeks after start of the intervention
|
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
Short term, 7 weeks after start of the intervention
|
Pain during activity (running) measured with Visual Analogue Scale (VAS) POST
Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)
|
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
Post, 14 weeks after start of the intervention (when intervention is finished)
|
Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP
Time Frame: 52 weeks after start of the intervention
|
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
|
52 weeks after start of the intervention
|
Treatment satisfaction PRE
Time Frame: Baseline, 1 week before start of the intervention
|
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
|
Baseline, 1 week before start of the intervention
|
Treatment satisfaction SHORT-TERM
Time Frame: Short term, 7 weeks after start of the intervention
|
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
|
Short term, 7 weeks after start of the intervention
|
Treatment satisfaction POST
Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)
|
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
|
Post, 14 weeks after start of the intervention (when intervention is finished)
|
Treatment satisfaction FOLLOW UP
Time Frame: 52 weeks after start of the intervention
|
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
|
52 weeks after start of the intervention
|
Lower limb Strength measured with hand-held dinamometer PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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.
|
Baseline, 1 week before start of the intervention
|
Lower limb Strength measured with hand-held dinamometer POST
Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)
|
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.
|
Post, 14 weeks after start of the intervention (when intervention is finished)
|
Lower limb Strength measured with hand-held dinamometer SHORT TERM
Time Frame: Short term, 7 weeks after start of the intervention
|
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.
|
Short term, 7 weeks after start of the intervention
|
Lower limb Strength measured with hand-held dinamometer FOLLOW UP
Time Frame: 52 weeks after start of the intervention
|
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.
|
52 weeks after start of the intervention
|
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE
Time Frame: Baseline, 1 week before start of the intervention
|
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.
|
Baseline, 1 week before start of the intervention
|
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST
Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)
|
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.
|
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)
Time Frame: Baseline, 1 week before start of the intervention
|
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.
|
Baseline, 1 week before start of the intervention
|
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: Short term, 7 weeks after start of the intervention
|
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.
|
Short term, 7 weeks after start of the intervention
|
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)
|
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.
|
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)
Time Frame: 52 weeks after start of the intervention
|
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.
|
52 weeks after start of the intervention
|
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Additional Relevant MeSH Terms
Other Study ID Numbers
- DOSIS&TENDON
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tendinopathy
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University of CadizNot yet recruitingTendinopathy | Achilles Tendinopathy | Tendinopathy, Elbow | Patellar Tendinopathy | Tendinopathy Rotator CuffSpain
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
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Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
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Brooke Army Medical CenterRecruitingLateral Elbow TendinopathyUnited States
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Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
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Elif Balevi BaturCompleted
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University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
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Anika Therapeutics, Inc.Completed
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Musculoskeletal Injury Rehabilitation Research...The Geneva Foundation; Fort Belvoir Community HospitalRecruitingAchilles TendinopathyUnited States
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Gelderse Vallei HospitalRecruiting
Clinical Trials on Best current practice exercise programme
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National University Health System, SingaporeRecruiting
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VA Office of Research and DevelopmentCompletedDiabetes | Foot UlcerUnited States
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Marmara UniversityUnknown
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Tufts UniversityUnited States Army Research Institute of Environmental MedicineCompleted
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Royal College of Surgeons, IrelandRecruitingInflammatory Bowel DiseasesIreland
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Norwegian University of Science and TechnologySt. Olavs HospitalCompleted
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University of AdelaideAustralian Catholic University; La Trobe UniversityRecruitingDiet Quality | Time-restricted EatingAustralia
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
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University of Southern DenmarkNational Board of Health, Denmark; The County of Funen, Denmark; The County of...UnknownMotivation | Physical Inactivity | Behavior ChangeDenmark
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Emory UniversityNational Cancer Institute (NCI); National Center for Complementary and Integrative...RecruitingLymphoma | Multiple MyelomaUnited States