Rehabilitation Program in Patients With Acromegaly

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Brief Title

Rehabilitation Program in Patients With Acromegaly

Official Title

Impact of a Physical Rehabilitation Program on the Quality of Life of Patients With Acromegaly: a Non-randomized Clinical Trial.

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.
    

Detailed Description

      Acromegaly is a rare, chronic, disabling disease of endocrine origin that causes several
      debilitating systemic dysfunctions due to the excessive production of growth hormone (GH) and
      insulin-like growth factor I (IGF-I) (Gadelha et al., 2017).

      In 98% of cases, the disease is caused by a sporadic somatotropinoma. Sporadic
      somatotropinomas are tumors of monoclonal origin; a mutation that activates the alpha subunit
      of stimulatory G protein (sgp) is the most common genetic alteration, and it is found in
      approximately 40% of participants. Somatrotopinomas can be macro- (≥1 cm) or microadenomas
      (<1 cm); purely GH-secreting (60% of cases), mixed (GH, prolactin, thyroid-stimulating
      hormone and/or corticotrophin) and occasionally pituitary carcinomas (fewer than 20 published
      cases); and, even more rarely, hypothalamic neoplasms secreting growth hormone-releasing
      hormone (GHRH), which stimulates the pituitary gland's production of GH. However, there may
      occasionally be secondary causes or ectopic sources of GHRH. Typical secondary sources
      include malignant neoplasms of the adrenals, lungs and pancreas; more rarely, GHRH is
      secreted by neuroendocrine tumors of the gastrointestinal tract, such as gastrinomas and
      insulinomas. GH-secreting ectopic tumors (pancreatic islet tumor and non-Hodgkin's lymphoma)
      occur very rarely (Chanson and Salenave, 2008; Chanson et al., 2009).

      In a smaller percentage of cases (5%), the disease may have a familial nature, such as
      multiple endocrine neoplasia syndromes type 1 and type 4, Carney complex, and familial
      isolated pituitary adenoma (FIPA), including its subtype, isolated familial somatotropinoma
      (IFS) (Gadelha et al., 2017; Marques et al., 2017). There are anecdotal reports of the
      disease being caused by an overdose of GH during treatment for children who do not produce
      this hormone and in athletes who use GH as a drug to improve muscle performance (Macintyre
      1987; Karges et al. 2004).

      Chronic exposure to GH and IGF-I has multisystemic repercussions, with changes in metabolic
      parameters, body composition, cardiac function, pulmonary function, muscle function and
      exercise capacity, among other effects (Dantas et al., 2013; Hatipoglu et al., 2014; Volschan
      et al., 2017). IGF-I is produced primarily by the liver (which is responsible for ≈75% of
      circulating IGF-I) in response to elevated GH levels and, to a lesser extent, to endocrine
      stimulation of insulin in the liver (Aguirre et al., 2016). Additionally, IGF-I provides an
      inhibitory feedback signal for GH secretion in the hypothalamus, stimulating the production
      of somatostatin in the pituitary (Ohlsson et al., 2009). IGF-I is also produced locally in
      various body tissues, including cartilaginous cells (Aguirre et al., 2016). The availability
      of IGF-I is tightly regulated by insulin-like growth factor binding proteins (IGFBPs)
      (Rajpathak et al., 2009). Elevated levels of IGF-I affect several pathways of metabolism,
      including (1) competition with insulin for the insulin receptor, resulting in diabetes
      mellitus; (2) general somatic hypertrophy (e.g., macroglossia, acromegalic heart, large
      kidneys and bulky skeletal muscles); and (3) binding to insulin-like growth factor-1 receptor
      (IGF-1R), which is a tyrosine kinase receptor that causes the phosphorylation and activation
      of various intracellular signaling pathways, including the activation of the AKT pathway,
      which results in the growth and proliferation of somatic cells (Cruzat et al., 2008; Aguirre
      et al., 2016; Adigun and Mesfin, 2017).

      Many of the clinical manifestations of acromegaly are common to other, more prevalent
      diseases, and diagnosis is often delayed by approximately 8 to 10 years after the onset of
      the first signs and symptoms (Brue and Castinetti, 2016). Adult participants with acromegaly
      have the characteristic features of forehead protrusion, nose and lip augmentation,
      nasolabial sulcus accentuation, prognathism, and enlarged hands and feet (Adigun and Mesfin,
      2017). Acromegaly can lead to visceromegaly, hypertension, arrhythmias, cardiomyopathy,
      diabetes mellitus, ventilatory dysfunction, sleep apnea, osteoarthritis and compressive
      neuropathies (Colaco et al., 2004; Pivonello et al., 2017). These participants may also
      present with general fatigue, headache, visual changes, hyperhidrosis, acanthosis nigricans,
      hypopituitarism, hyperprolactinemia, nephrocalcinosis and an increased incidence of colon and
      thyroid cancer (Table 1) (Colao et al., 2004). The clinical diagnosis is confirmed
      biochemically by an elevated IGF-I level for age and a nadir serum GH concentration higher
      than 1.0 μg/L following an oral glucose tolerance test (Katznelson et al., 2014). The
      assessment of tumor volume and extent is based on imaging studies using magnetic resonance
      imaging or computed tomography of the sella turcica (Melmed et al., 2005). The goals of
      treatment are to correct (or prevent) tumor compression by excision, reduce GH and IGF-I
      levels to normal, control symptoms, improve quality of life and reduce mortality (Cordido et
      al., 2013, Leopoldo et al., 2017). Transsphenoidal surgery is the treatment of choice, with
      exceptions for participants who have a clinical contraindication or who refuse the procedure
      or in cases of almost entirely unresectable tumors (e.g., those with an epicenter within the
      cavernous sinus) (Katznelson et al., 2014). When surgery fails to correct GH/IGF-I
      hypersecretion, adjuvant drug treatment is indicated. At present, there are three classes of
      drugs available for the treatment of acromegaly: somatostatin receptor ligands, dopaminergic
      agonists, and GH receptor antagonists (Giustina et al., 2014, Katznelson et al., 2014).
      Radiation therapy is currently proposed as a third-line treatment (Chanson et al., 2009;
      Leopoldo et al., 2017). The prognosis of acromegaly has improved in recent years. However,
      even when participants are cured or their disease is well controlled, sequelae often remain
      (Leopoldo et al., 2017).

      There are innumerable functional limitations that negatively affect the ability of
      participants with acromegaly to perform activities of daily living (ADLs) and contribute to
      the deterioration of their health-related quality of life (HRQoL). The dysfunctions that
      occur in acromegaly mainly involve the bones, joints and muscles, and these structures are
      affected in almost all cases (Lopes et al., 2014; Lopes et al., 2014; Mazziotti et al.,
      2018). In participants with acromegaly, progressive damage to the articular and
      musculoskeletal systems occurs, causing temporomandibular joint dysfunction, hypertrophic
      arthropathy, chrondrocalcinosis, limitations of joint mobility, genu varum, acroparesthesias,
      carpal tunnel syndrome, thoracic spine kyphoscoliosis, intermittent claudication (lumbar
      spinal stenosis) and proximal myopathy (Colao et al., 2004; Chanson and Salenave, 2008;
      Pivonello et al., 2017). Acromegaly is associated with significant alterations in both
      peripheral muscle strength and endurance; these participants have reduced muscle strength
      despite the marked muscular hypertrophy described in previous skeletal muscle biopsy studies
      (Nagulesparen et al., 1976; Guedes da Silva et al., 2013; Lopes et al., 2015). Acromegalic
      arthropathy affects both axial and peripheral sites; the knee is the joint most often
      involved, followed by the shoulder, hip, ankle, elbow and hand joints (Colao et al., 2004;
      Scacchi and Cavagnini, 2006). Consequently, joint pain had been described in up to 90% of
      acromegalic participants and negatively impacts their HRQoL (Crespo et al., 2017).

      In acromegaly, arthropathy progresses inexorably in advanced stages and unpredictably in
      smaller ways; it is not influenced by successful treatment of the disease, except in the case
      of diffuse joint symptoms and some pain sites (Chanson and Salenave, 2008; Chanson et al.,
      2009). In terms of skeletal muscle, two recent studies showed a paradoxical reduction in
      muscle mass and an increase in proximal muscle fatigue in participants who achieved
      biochemical control of acromegaly (Bredella et al., 2017; Füchtbauer et al., 2017). However,
      to our knowledge, no controlled trial has investigated the effects of successful treatment of
      the disease on muscle function, as determined by measures of skeletal muscle performance.
      Given the advances in the treatment of acromegaly, it seems appropriate to assess the impact
      of these costly interventions on physical performance and functional abilities in
      participants with different degrees of GH/IGF-I control. Despite the important functional
      limitations resulting from the involvement of the osteomyoarticular system, rehabilitation
      programs are currently recommended for this population.

      In recent years, HRQoL has been considered as an important factor in the clinical management
      of acromegaly (Crespo et al., 2017). In these for this patient population, HRQoL is impaired
      even after clinical treatment and the normalization of the target biochemical values, i.e.,
      GH and IGF-I, which suggests that new therapeutic approaches should be sought to improve
      functionality (Geraedts et al., 2017, Kyriakakis et al., 2017, Webb et al., 2017). Several
      investigators have hypothesized the possible benefits of ADL rehabilitation for this group of
      people, tracing the profile of changes that occur in this population throughout life and
      identifying the most important points and the main deficiencies and discomforts reported.
      However, only two studies have objectively evaluated the contributions of regular physical
      exercise to the physical and cardiovascular performance of acromegalic participants with the
      aim of characterizing the importance of physical activity in cases of physical and emotional
      impairments (Hatipoglu et al., 2014; Hatipoglu et al., 2015). Despite these studies, data on
      physical performance in acromegaly are limited, and physiotherapeutic approaches to such
      dysfunctions and with their impacts on participants well-being are still poorly established
      (Dantas et al., 2013, Guedes da Silva et al., 2013, Lopes et al., 2015). The investigators
      believe that individuals with acromegaly may benefit from a protocol of physiotherapeutic
      treatment directed towards controlling functional limitations.
    


Study Type

Interventional


Primary Outcome

Isometric dynamometry with surface electromyography

Secondary Outcome

 Walk test of six minutes (6MWT)

Condition

Acromegaly

Intervention

Physical activity

Study Arms / Comparison Groups

 Physical activity
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

January 10, 2016

Completion Date

October 10, 2019

Primary Completion Date

September 10, 2019

Eligibility 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.
      

Gender

All

Ages

18 Years - 64 Years

Accepts Healthy Volunteers

No

Contacts

Tatiana l Lima, Msc, (21)995555183, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT03710499

Organization ID

Clinical trial in acromegaly


Responsible Party

Sponsor

Study Sponsor

Centro Universitário Augusto Motta

Collaborators

 Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Study Sponsor

Tatiana l Lima, Msc, Principal Investigator, Centro Universitário Augusto Motta


Verification Date

October 2018