Physical Rehabilitation in Sickle Cell Anemia

NCT04705792 | Unknown DMC

• 1 other identifier: 1.718.917/2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia; Muscle Dysfunction; Quality of Life; Physical Activity; Exercise

Keywords

Sickle Cell Anemia; Rehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (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.

  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).

  12 weeks

Secondary Outcomes (2)

• Peripheral muscle function before and after the execution of the treatment plan.

  12 weeks

• Functional capacity through the 6-minute walk test (6MWT) before and after the execution of the treatment plan.

  12 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 12 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 - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Presence of comorbidities not related to sickle cell anemia.
• Patients with inability to perform the six-minute walk test.
• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Agnaldo José Lopes

Rio de Janeiro, 22745-271, Brazil

RECRUITING

Related Publications (12)

• Almeida A, Roberts I. Bone involvement in sickle cell disease. Br J Haematol. 2005 May;129(4):482-90. doi: 10.1111/j.1365-2141.2005.05476.x.

  PMID: 15877730 RESULT

• Baltich J, Emery CA, Stefanyshyn D, Nigg BM. The effects of isolated ankle strengthening and functional balance training on strength, running mechanics, postural control and injury prevention in novice runners: design of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 4;15:407. doi: 10.1186/1471-2474-15-407.

  PMID: 25471989 RESULT

• Chatel B, Hourde C, Gondin J, Foure A, Le Fur Y, Vilmen C, Bernard M, Messonnier LA, Bendahan D. Impaired muscle force production and higher fatigability in a mouse model of sickle cell disease. Blood Cells Mol Dis. 2017 Mar;63:37-44. doi: 10.1016/j.bcmd.2017.01.004. Epub 2017 Jan 11.

  PMID: 28110136 RESULT

• Chaturvedi S, DeBaun MR. Evolution of sickle cell disease from a life-threatening disease of children to a chronic disease of adults: The last 40 years. Am J Hematol. 2016 Jan;91(1):5-14. doi: 10.1002/ajh.24235.

  PMID: 26547630 RESULT

• Dougherty KA, Schall JI, Rovner AJ, Stallings VA, Zemel BS. Attenuated maximal muscle strength and peak power in children with sickle cell disease. J Pediatr Hematol Oncol. 2011 Mar;33(2):93-7. doi: 10.1097/MPH.0b013e318200ef49.

  PMID: 21228717 RESULT

• Maioli MC, Soares AR, Bedirian R, Alves UD, de Lima Marinho C, Lopes AJ. Relationship between pulmonary and cardiac abnormalities in sickle cell disease: implications for the management of patients. Rev Bras Hematol Hemoter. 2016 Jan-Feb;38(1):21-7. doi: 10.1016/j.bjhh.2015.11.001. Epub 2015 Dec 11.

  PMID: 26969771 RESULT

• Milner PF, Kraus AP, Sebes JI, Sleeper LA, Dukes KA, Embury SH, Bellevue R, Koshy M, Moohr JW, Smith J. Sickle cell disease as a cause of osteonecrosis of the femoral head. N Engl J Med. 1991 Nov 21;325(21):1476-81. doi: 10.1056/NEJM199111213252104.

  PMID: 1944426 RESULT

• Ohara DG, Ruas G, Walsh IA, Castro SS, Jamami M. Lung function and six-minute walk test performance in individuals with sickle cell disease. Braz J Phys Ther. 2014 Jan-Feb;18(1):79-87. doi: 10.1590/s1413-35552012005000139.

  PMID: 24675916 RESULT

• Piel FB, Patil AP, Howes RE, Nyangiri OA, Gething PW, Dewi M, Temperley WH, Williams TN, Weatherall DJ, Hay SI. Global epidemiology of sickle haemoglobin in neonates: a contemporary geostatistical model-based map and population estimates. Lancet. 2013 Jan 12;381(9861):142-51. doi: 10.1016/S0140-6736(12)61229-X. Epub 2012 Oct 25.

  PMID: 23103089 RESULT

• Ravelojaona M, Feasson L, Oyono-Enguelle S, Vincent L, Djoubairou B, Ewa'Sama Essoue C, Messonnier LA. Evidence for a profound remodeling of skeletal muscle and its microvasculature in sickle cell anemia. Am J Pathol. 2015 May;185(5):1448-56. doi: 10.1016/j.ajpath.2015.01.023. Epub 2015 Mar 13.

  PMID: 25773175 RESULT

• Rubio MA, Diez L, Alvarez N, Munteis E. [Muscle involvement in sickle cell disease]. Med Clin (Barc). 2015 Nov 6;145(9):413-4. doi: 10.1016/j.medcli.2014.12.010. Epub 2015 Feb 7. No abstract available. Spanish.

  PMID: 25662725 RESULT

• Almeida CHS, Reis LFDF, Nascimento LPADS, Soares AR, Maioli MCP, Lopes AJ. Therapist-oriented home rehabilitation for adults with sickle cell anemia: effects on muscle strength, functional capacity, and quality of life. Hematology. 2021 Dec;26(1):612-619. doi: 10.1080/16078454.2021.1965736.

  PMID: 34411499 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Agnaldo J Lopes, PhD

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnaldo J Lopes, PhD

CONTACT

+552125762030; agnaldolopes.uerj@gmail.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 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.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: January 31, 2020
• Primary Completion: July 25, 2021
• Study Completion: July 30, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)