Rehabilitation Program in Patients With Acromegaly

NCT03710499 | Unknown DMC

• 1 other identifier: Clinical trial in acromegaly
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly; Muscle Dysfunction; Physical Activity; Exercise

Keywords

Acromegaly; Rehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Isometric dynamometry with surface electromyography

  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.

  eight weeks

Secondary Outcomes (1)

• Walk test of six minutes (6MWT)

  eight weeks

Other Outcomes (5)

• Acromegaly Quality of Life Questionnaire (AcroQol)

  eight weeks

• Functional Assessment of Chronic Illness Therapy-Fatigue - (FACIT-F)

  eight weeks

• Lower Extremity Functional Scale (LEFS)

  eight weeks

Study Arms (1)

Physical activity

EXPERIMENTAL

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

Interventions

Physical activity PROCEDURE

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.

Physical activity

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Centro universitário augusto motta

Rio de Janeiro, Rio de Janeiro, 21041-020, Brazil

RECRUITING

MeSH Terms

Conditions

Acromegaly; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tatiana l Lima, Msc

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana L Lima, Msc

CONTACT

(21)995555183; tatiana_trll@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 18, 2018
• Study Start: January 10, 2016
• Primary Completion: September 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

BR (1)