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Rehabilitation Program in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Centro Universitário Augusto Motta

Brief Summary:
Acromegaly is chronic, systemic and highly disabling disease. People with Acromegaly show a significant reduction in peripheral muscle strength associated with a loss resistance and lethargy. They tend the fatigue more easily when compared to individuals without the disease, which involves exercise intolerance and disability resulting in a quality of life impaired. Acromegaly have important functional limitations that adversely affect the performance in the activities of day-to-day and contribute to the worsening of the disease. Based on previous studies, the investigators believe that acromegaly participants with would have benefit from a treatment protocol facing physical performance and improved quality of life. Main Objective: To evaluate the effect of home rehabilitation on quality of life of participants with acromegaly. Methods: In this study of longitudinal intervention, they will undergo a rehabilitation program lasting three months, three times a week lasting 60 minutes each session. The protocol will be the assessment of Acromegaly Quality of Life Questionnaire (AcroQol) questionnaire, functional assessment by the walk test of six minutes (6MWT), peripheral muscle strength and assessment of joint integrity, fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire that evaluates the fatigue in the chronic participants. The assessment will be in 3 different moment (month 0, month 2 month 3). The treatment protocol will consist of warm-up and cool-down, strengthening exercise and muscular endurance, aerobic training, and balance training and proprioception. Prospects: The participants with acromegaly will benefited significantly after undergoing a physical therapy rehabilitation protocol the following parameters: Resistance and muscle strength, pain conditions and disorders skeletal muscle, improvement in activities of daily living and consequent better quality of life.

Condition or disease Intervention/treatment Phase
Acromegaly Muscle Dysfunction Physical Activity Exercise Procedure: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acromegaly, of both sexes, older than 18 and younger than 65 years, either with active or controlled disease.
  • Patients who present clinical stability and who are eligible for the treatment protocol (patients with hormone deficiency will continue on replacement therapy - SILVA et al., 2013).
  • Signature of the Informed Consent Term (TCLE).

Exclusion Criteria:

  • Patients with inability to perform the 6MWT, according to ATS criteria.
  • Patients who have cognitive impairment by mini mental state examination (MEEN).
  • Abandonment of treatment during the application of the protocol.
  • Uncontrolled hypertension (> 180/100 mmHg with medication use).
  • Use of psychotropic drugs.
  • Any significant limitations due to osteoarthropathy.
  • History of surgery in the previous year with exercise restriction. Não Untreated hypothyroidism or hypocortisolism (HUBBLE et al., 2014).
  • IPAQ with very active classification.

Information from the National Library of Medicine

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


Contacts
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Contact: Tatiana L Lima, Msc (21)995555183 tatiana_trll@hotmail.com

Locations
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Brazil
Centro universitário augusto motta Recruiting
Rio De Janeiro, RJ, Brazil, 21041-020
Contact: Agnaldo J Lopes, Msc    (21)38829797 ext 2012    agnaldolopes.uerj@gmail.com   
Sub-Investigator: Tatiana Lima, Msc         
Principal Investigator: Agnaldo Lopes, Phd         
Sponsors and Collaborators
Centro Universitário Augusto Motta
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Tatiana l Lima, Msc Centro Universitário Augusto Motta
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Responsible Party: Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT03710499    
Other Study ID Numbers: Clinical trial in acromegaly
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data available in scientific environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro Universitário Augusto Motta:
Acromegaly
Rehabilitation
Physiotherapy
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases