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
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia Muscle Dysfunction Quality of Life Physical Activity Exercise||Procedure: Physical activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|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|
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.
- 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).
- 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.
- 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.
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
|Contact: Agnaldo J Lopes, PhDfirstname.lastname@example.org|
|Agnaldo José Lopes||Recruiting|
|Rio de Janeiro, Brazil, 22745-271|
|Contact: Agnaldo J Lopes, PhD 2125762030 email@example.com|
|Principal Investigator:||Agnaldo J Lopes, PhD||Centro Universitário Augusto Motta|