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Resistance and Progressive Training Program for Rehabilitation of People With Patellofemoral Pain

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ClinicalTrials.gov Identifier: NCT03985254
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriela Souza de Vasconcelos, Universidade Federal de Sao Carlos

Brief Summary:
Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life, interfering with work, daily activities and physical exercise. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of patients with PFP, exercise protocols (including load progression) are not clearly described, hindering their applications in clinical practice and research. Therefore, the objective of this study is to verify if the improvement in pain intensity, function, kinesiophobia, self-perception of improvement, quality of life and muscle function variables after a resistance and progressive training program is superior to that observed in a training with minimum load. This study will be randomized and controlled, developed with individuals with PFP, allocated in one of two groups: Resistance and Progressive Training Group (RPTG) and Minimum Load Training Group (MLTG). Primary outcomes will be intensity of pain and function, while secondary outcomes will be kinesiophobia; self-perception of improvement; quality of life; the peak of isometric abductor and hip extensor torque, and knee extensor; and the rate of torque development of the abductor and hip extensor muscles, and knee extensors at 30% and 90% of maximal isometric torque. Participants from both groups will be evaluated before the intervention (pre) and after the intervention (post). Data analysis will follow the intention-to-treat principle. To compare the groups at different times (PRE and POST) will be used the two-way ANOVA with mixed model, with Bonferroni post hoc to identify the specific differences. The level of significance will be 0.05.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Resistive and Progressive Training Group (RPTG) Other: Minimum Load Training Group (MLTG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Resistance and Progressive Training Program for Rehabilitation of People With Patellofemoral Pain: Randomized and Controlled Clinical Trial
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Resistive and Progressive Training Group (RPTG)
The resistance and progressive training program was based on a pilot study that successfully applied the protocol on 10 participants with PFP (data to be published). This training program, which will be held three times a week for 12 weeks, will consist of the use of resistance and progressive exercises to gain strength and muscular power and will be based on the training principles recommended by the American College of Sport Medicine (GARBER et al, 2011). At each training session, at least five exercises (of a total of 15 exercises) will be chosen by the researcher and applied according to the purpose of the session, ie strength, strength or power. Of these five exercises, one will be for hip extensors, one for hip abductors, one for knee extensors and two for trunk.
Other: Resistive and Progressive Training Group (RPTG)
The resistance and progressive training program was based on a pilot study that successfully applied the protocol on 10 participants with DPF (data to be published). This training program, which will be held three times a week for 12 weeks, will consist of the use of resistance and progressive exercises to gain strength and muscular power and will be based on the training principles recommended by the American College of Sport Medicine (GARBER et al, 2011).

Active Comparator: Minimum Load Training Group (MLTG)
Participants who are assigned to the Minimum Load Training Group will perform an exercise program three times a week for 12 weeks. The exercises will be the same, but without load increase (body weight, only), without the progression of load, and without the power component that will also be performed in the other group. In the same way as in the other group, at each training session, at least five exercises (out of a total of 15 exercises) will be chosen and applied to the participants. Of these five exercises, one will be for hip extensors, one for hip abductors, one for knee extensors and two for trunk. If participants do not hold at least two sessions in a week, they will be asked to repeat the week; and this will be allowed until the protocol does not exceed 16 weeks.
Other: Minimum Load Training Group (MLTG)
Participants who are assigned to the Minimum Load Training Group will perform an exercise program three times a week for 12 weeks. The exercises will be the same, but without load increase (body weight, only), without the progression of load, and without the power component that will also be performed in the other group.




Primary Outcome Measures :
  1. Change from baseline pain Intensity at 12 weeks [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up) ]
    Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating extremely intense pain. Participants will indicate their usual pain and their worst pain during the last week (CROSSLEY et al, 2004). The VAS scores will be computed by measuring the length of the line, in millimeters, from the left end (without pain) until the mark made by the participant.

  2. Change from baseline physical function at 12 weeks [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up) ]
    The Anterior Knee Pain Scale, a translated and validated Portuguese version (DA CUNHA et al, 2013), will be used to evaluate subjective symptoms, such as anterior knee pain and functional limitations related to PFP. The items assessed in the questionnaire are patellar subluxation, lameness, pain, walking, climbing stairs and remaining seated for prolonged time with knees flexed. It has scores of 0 to 100 points, where 100 means no pain and / or functional limitations and 0 means constant pain and several functional limitations (KUJALA et al, 1993). The Anterior Knee Pain Scale is a reliable and valid instrument to evaluate the function in individuals with PFP (CROSSLEY et al, 2004). The final score will be used for statistical analysis.


Secondary Outcome Measures :
  1. Kinesiophobia [ Time Frame: Pre (baseline) treatment and post treatment (12 weeks) ]
    The kinesiophobia will be assessed using the translated and validated version of the Tampa Scale for Kinesiophobia questionnaire (SIQUEIRA et al, 2007), which is composed of 17 items that evaluate fear of movement, injury or recurrence of injury (MILLER, 1991). This questionnaire is a four-point Likert scale, in which the sum of responses can vary from 17 to 68, and scores greater than 37 indicate the presence of kinesiophobia.

  2. Self-perception of improvement [ Time Frame: Pre (baseline) treatment and post treatment (12 weeks) ]
    The global rating of change (GRC) scale is a 15-point, single-item scale that measures the patient's im¬pression of improvement in health status following treatment (JAESCHKE et al, 1989). The scale is scored from -7 (a very great deal worse) to +7 (a very great deal better), with 0 (zero) indicating that there was no change. Changes of 4 points or more in this scale were previously considered to be clinically important in patients with knee pain.

  3. Change Quality of Life [ Time Frame: Pre (baseline) treatment and post treatment (12 weeks) ]
    Participants' quality of life will be assessed through the Knee Injury and Osteoarthritis Outcome Score (KOOS). This questionnaire is composed of 42 items, divided into 5 sub-scales, which assess: pain, symptoms, function in sports and recreational activities, function in daily life activities and quality of life in adults with knee injuries (ligaments, meniscal) including post-traumatic osteoarthrosis. In the present study, only the sub-scale of quality of life will be applied to participants. This sub-scale is composed of four questions and each one will be scored from 0 to 4, 0 representing extreme knee problems and 4 that there are no problems in the knee. The sum of these questions will be used for further analysis.

  4. Maximal Isometric Torque and Rate of Force Development (RFD) [ Time Frame: Pre (baseline) treatment and post treatment (12 weeks) ]

    The maximal isometric torque of the hip abductors and extensors, and knee extensors, as the rate of force development, will be assessed using an isokinetic dynamometer (Biodex MultiJoint System 3, Biodex Medical Systems Inc., New York, USA), with a sampling frequency of 100 Hz.

    To calculate the RFD of the hip abductors and extensors and knee extensors, the data of the repetitions in which the participants reached the highest isometric torque will also be used (NUNES et al, 2018). The normalized torque data will be exported and processed in Matlab software.

    The evaluation of the RFD will be performed by calculating the slope of the torque/time curve. The slope will be obtained by dividing the normalized torque variation (Nm/kg × 100, represented as %) by the time variation (ms) from the start of the contraction until 30% and 90% of the maximal isometric torque (BELLEW, 2002; CHANG et al, 2005).




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women with bilateral or unilateral patellofemoral pain

Exclusion Criteria:

  • history of knee surgery
  • history of hip or lumbar spine injury or pain
  • patellar instability
  • pain on palpation of the patellar tendon, iliotibial band, Hoffa fat, goose paw tendons or knee joint line
  • signs or symptoms of meniscal or knee ligament injuries
  • presence of Osgood-Schlatter syndrome or Sinding-Larsen-Johansson syndrome
  • any vestibular, neurological or musculoskeletal alterations that interfere or contraindicate the procedures of this study

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Responsible Party: Gabriela Souza de Vasconcelos, Post graduate, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03985254     History of Changes
Other Study ID Numbers: LaiotUFSCAR
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases