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Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)

NCT ID: NCT03853122

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Tendinopathy

Keywords

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tendinopathy exercise dosage physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, with two parallel groups (control and intervention)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors are not aware of the allocation group of the participants

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Best current practice exercise programme

Intervention Type OTHER

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 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

Group Type EXPERIMENTAL

Experimental exercise programme

Intervention Type OTHER

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.

Interventions

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Best current practice exercise programme

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

Intervention Type OTHER

Experimental exercise programme

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.

Intervention Type OTHER

Other Intervention Names

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Alfredson protocol LEAP protocol MaLaGa protocol

Eligibility Criteria

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Inclusion Criteria

1. People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
2. Pain duration for at least one month.

Exclusion Criteria

1. Corticosteroid injection in the studied tendon in the last 12 months;
2. Other injuries in the affected lower limb in the last 12 months;
3. Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
4. Tendinous rupture history in the affected lower limb;
5. Systemic diseases such as rheumatic arthritis or diabetes mellitus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role collaborator

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34404699 (View on PubMed)

Other Identifiers

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DOSIS&TENDON

Identifier Type: -

Identifier Source: org_study_id