Rehabilitation Program in Patients With Acromegaly
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|ClinicalTrials.gov Identifier: NCT03710499|
Recruitment Status : Unknown
Verified October 2018 by Centro Universitário Augusto Motta.
Recruitment status was: Recruiting
First Posted : October 18, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acromegaly Muscle Dysfunction Physical Activity Exercise||Procedure: Physical activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted two months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 3 different timepoints (baseline, after 8 weeks of training, and after a 4-week washout period with no treatment); thus, he served as his own control. The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment. Throughout the application of the protocol, the patient regularly maintained his follow-up visits with the multidisciplinary team. Moreover, there was no change in pharmacological treatment throughout this period.|
|Masking:||None (Open Label)|
|Official Title:||Impact of a Physical Rehabilitation Program on the Quality of Life of Patients With Acromegaly: a Non-randomized Clinical Trial.|
|Actual Study Start Date :||January 10, 2016|
|Estimated Primary Completion Date :||September 10, 2019|
|Estimated Study Completion Date :||October 10, 2019|
Experimental: Physical activity
The program comprises the practice of resistance exercises for the main muscular groups, with free weights and with their own body weight against the action of gravity, the proposal consists of 3 weekly sessions, for 8 consecutive weeks.
Procedure: Physical activity
Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit.
- Isometric dynamometry with surface electromyography [ Time Frame: eight weeks ]Peripheral muscle strength and fatigue strength will be evaluated using an EMG -810 surface electromyograph and a DIN_TRO traction dynamometer. For the strength test, the muscle evaluated will be the femoral quadriceps, the patient will be instructed to perform the knee extension, with the highest possible isometric force. Your positioning will be seated with your hands crossed over the chest, with the upright trunk adjusted by the backrest in order to allow the angle of 90 ° for hip flexion. For analysis of fatigue strength, surface electromyography of the medial vastus muscle (VM) of the dominant lower limb will be used through the 8-channel surface electromyograph from the gross signal. The endurance test consists of a contraction sustained for 60 seconds using 50% of the highest MIVM obtained in the strength test.
- Walk test of six minutes (6MWT) [ Time Frame: eight weeks ]For the execution of the TC6M, the patient will be previously oriented to use sneakers and comfortable clothing. Later it will be positioned in a corridor of 30 meters, demarcated every 3 meters and oriented to walk as fast as possible, but without running, for a total period of 6 minutes. Peripheral saturation of O2 (SpO2), heart rate (HR), modified Borg scale, blood pressure (BP) during the test will be checked. There will be two tests with a 30 minute interval between them. The distance selected will be the patient's best performance. This is based on reducing the learning effect. Subsequently, the data found will be associated with the forecast of Britto et al. (2013) according to age, height and body weight of each individual.
- Acromegaly Quality of Life Questionnaire (AcroQol) [ Time Frame: eight weeks ]The Acromegaly Quality of Life Questionnaire (AcroQol) is a specific, simple and valid instrument for assessing quality of life in people suffering from acromegaly aged 18-70 years. It can be used in two different fields: in clinical trials of new drugs as well as in the follow-up of patients in clinical practice. This is particularly useful in evaluating the effects of intervention or treatment. The questionnaire is one-dimensional and contains 22 items divided into two scales: one that evaluates physical aspects (eight items) and another that evaluates the psychological aspects (14 items). The latter is also divided into two sub-scales: one evaluates physical appearance and another evaluates the impact of the disease on the patient's personal relationships (seven items each). The score is given from 1 to 5 where, the lower the score, the worse the quality of life.
- Functional Assessment of Chronic Illness Therapy-Fatigue - (FACIT-F) [ Time Frame: eight weeks ]The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale was developed for individuals with chronic diseases to evaluate health-related quality of life, treating fatigue as a multidimensional concept. This scale has been applied in different groups of patients with different types of dysfunctions. FACIT-F is a specific scale of evaluation of fatigue that has good representation of the individual's frame, considered as an instrument of easy application, and its use authorized by the author of the same. It will be answered by the researcher himself, with 13 questions ranging from 0 to 4, where the higher the score, the less fatigue. Your score goes from 0 to 52.
- Lower Extremity Functional Scale (LEFS) [ Time Frame: eight weeks ]The Lower Extremity Functional Scale (LEFS) is a self-administered questionnaire for orthopedic assessment of lower limb integrity. It was developed according to the concepts of functionality and disability of the World Health Organization (WHO). This scale comprises 20 questions and each has a score that varies between the minimum of zero (extremely difficult) and the maximum of four points (without difficulty). The sum of all items can generate a maximum total of 80 points. Such a level of punctuation suggests a normal functional state, that is, the higher the value obtained, the higher the level of functionality of the individual. The LEFS scale is easy to apply and can be used at different levels of functionality and disability related to the lower limbs. It is usually used in initial evaluations, during treatment and thereafter, in order to establish new therapeutic goals for patients.
- Weight (kg) and Height (m) [ Time Frame: eight weeks ]Body weight and height of patients will be measured using a Filizola® mechanical scale with a maximum capacity of 150 kilograms and a sensitivity of 100 grams and a stadiometer. Body mass index (BMI) will be calculated by dividing body mass by height squared.
- Modified Borg Scale [ Time Frame: eight weeks ]Evaluates the perception of the degree of effort, performed during the exercise. Currently, it is used in the modified form described with a score varying with scores between 0 where the level of perception of dyspnea (fatigue) or muscle fatigue is "none" until 10 where the level of perception of dyspnea (fatigue) or muscle fatigue is " maximum".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710499
|Contact: Tatiana L Lima, Msc||(21)email@example.com|
|Centro universitário augusto motta||Recruiting|
|Rio De Janeiro, RJ, Brazil, 21041-020|
|Contact: Agnaldo J Lopes, Msc (21)38829797 ext 2012 firstname.lastname@example.org|
|Sub-Investigator: Tatiana Lima, Msc|
|Principal Investigator: Agnaldo Lopes, Phd|
|Principal Investigator:||Tatiana l Lima, Msc||Centro Universitário Augusto Motta|