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Physical Rehabilitation in Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT04705792
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Centro Universitário Augusto Motta

Brief Summary:
Sickle cell anemia (SCA) is one of the most neglected diseases worldwide, according to the World Health Organization. In the adult population with SCA, the systemic effects of the disease, such as respiratory and peripheral muscle dysfunction, cause a decrease in quality of life. As a consequence, there is a concern about functional rehabilitation, since the aging of this population is already a reality in our environment. Thus, the objective of this project is to evaluate the effects of functional rehabilitation on quality of life in adult patients over 18 years of SCA. In this longitudinal intervention study, patients will be submitted to a three-month rehabilitation program. Before and after the intervention, patients will be submitted to the following assessments: spirometry; quality of life questionnaire - Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36); functional scale of joint integrity - Lower Extremity Functional Scale (LEFS); fatigue assessment scale - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); physical activity assessment questionnaire - International Physical Activity Questionaire (IPAQ); peripheral muscle assessment (handgrip and isometric dynamometry of the quadriceps muscle); and 6-minute walk test (6MWT). The protocol will consist of warm-up and cool-down exercises, muscle strengthening and endurance exercises, aerobic training, balance training and proprioception. Thus, it is expected that patients with sickle cell anemia will benefit significantly, with a consequent improvement in musculoskeletal function, pain and health-related quality of life.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Muscle Dysfunction Quality of Life Physical Activity Exercise Procedure: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 three 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 2 different timepoints (baseline and after 12 weeks of training); 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: Physical Rehabilitation in Adults With Sickle Cell Anemia: Effects on Muscle Function, Functional Capacity and Quality of Life
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : July 25, 2021
Estimated Study Completion Date : July 30, 2021


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 12 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. Quality of life related to activities of daily living through the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) before and after the execution of the treatment plan. [ Time Frame: 12 weeks ]
    The SF-36 is composed of 11 questions and 36 items that comprise eight components (domains or dimensions), represented by functional capacity (10 items), physical aspects (four items), pain (two items), general health status (five items), vitality (four items), social aspects (two items), emotional aspects (three items), mental health (five items) and a comparative question about the current perception of health for a year. The individual receives a score in each domain, which ranges from 0 to 100, with 0 being the worst score and 100 being the best (PIMENTA et. Al, 2008).


Secondary Outcome Measures :
  1. Peripheral muscle function before and after the execution of the treatment plan. [ Time Frame: 12 weeks ]
    The peripheral muscle function will be evaluated through handgrip strength (HGS) and quadriceps strength (QS). HGS will be measured by a maximal isometric strength test with the SH5001 device (Saehan Corporation, Korea) in the dominant upper limb. The participants will be positioned according to standard recommendations, with their elbow flexed at 90°, the forearm half-pronated, and the wrist in a neutral position. HGS was summarized as the highest value of three attempts with a 60-s rest time. The QS will be evaluated with a tension dynamometer (sensor capacity = 200 kg, E-lastic 5.0, E-sports SE, Brazil). The range of motion within 90° during the test will be determined, starting at 90° flexion at the knee. The maximum force will be assessed in the dominant leg after a 5-s sustained isometric contraction. QS will be summarized as the highest value from three attempts with a 1-min intervals.

  2. Functional capacity through the 6-minute walk test (6MWT) before and after the execution of the treatment plan. [ Time Frame: 12 weeks ]
    The 6MWT will be performed according to previously described recommendations using a 30-m runway demarcated with cones at both ends. Blood pressure, heart rate, respiratory rate, peripheral oxygen saturation, and Borg's perceived exertion scale will be measured before and after the 6MWT.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sickle cell anemia, of both sexes, aged ≥ 18 years.
  • Patients who have clinical stability and are eligible for the treatment protocol.

Exclusion Criteria:

  • Presence of comorbidities not related to sickle cell anemia.
  • Patients with inability to perform the six-minute walk test.
  • Patients who have cognitive impairment that impairs their inclusion in the study.
  • Abandonment of treatment during the application of the protocol.
  • Uncontrolled hypertension or use of psychotropic drugs.
  • Any significant limitations due to osteoarthropathy.
  • Have had any orthopedic surgery in the previous year.

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): NCT04705792


Contacts
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Contact: Agnaldo J Lopes, PhD +552125762030 agnaldolopes.uerj@gmail.com

Locations
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Brazil
Agnaldo José Lopes Recruiting
Rio de Janeiro, Brazil, 22745-271
Contact: Agnaldo J Lopes, PhD    2125762030    agnaldolopes.uerj@gmail.com   
Sponsors and Collaborators
Centro Universitário Augusto Motta
Investigators
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Principal Investigator: Agnaldo J Lopes, PhD Centro Universitário Augusto Motta
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT04705792    
Other Study ID Numbers: 1.718.917/2016
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
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
Keywords provided by Centro Universitário Augusto Motta:
Sickle Cell Anemia
Rehabilitation
Physiotherapy
Additional relevant MeSH terms:
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Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn