Efficacy of Designed Exercise Program on Pain and Quality of Sleeping in Patient With Sickle Cell Disease Anemia.

NCT05894161 | Completed DMC

• 1 other identifier: IRB-UGS-2022-03-186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Pain and sleep disturbance are the most common problems experienced by adult patients with sickle cell disease anemia. Aim: the aim of this study is to evaluate the efficacy of designed exercise program on pain, and quality of sleeping in adult patients with sickle cell disease anemia and how the program affects their quality of lives. Subjects and methods: Adults patients with sickle cell diseases aging over 18 years old. Data will be collected in face-to-face interviews. Eligible participants will be equally and randomized into two groups. Group-1: Twenty-five adult patients with SCD will receive a designed exercise program of physical therapy for relief pain and improve sleep quality (experimental group). The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, three days per week for 6 weeks in addition to walking daily 30 minutes on the ground surface. Group-2: Twenty-five adult patients with SCD will participate as a control group they will not receive exercise program. Analysis: The collected data will be managed by using t -test and the repeated measures of ANOVA test to compare the significance within groups and between two groups.

Conditions

Sickle Cell Disease

Keywords

sleep disturbance; Fatigue; Stress; Quality of life

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  The (PSQI) is a 19-item instrument created to measure different aspects of sleep quality and sleep disturbance (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The scale reports quality of sleeping over the past month. The PSQI is divided into 7 subscale scores: subjective sleep quality; sleep latency (time of full sleep); duration; habitual sleep efficiency (proportion between total sleep time and time in bed); sleep disturbances (waking up during the night); use of medication to sleep; and daytime dysfunction (difficulty staying awake during daytime). The overall score ranges between 0 and 21, and a total score of more than 5 indicates poor sleep quality(Al Maqbali et al., 2020).

  10 minutes

• Visual Analog Scale:

  VAS: It is a safe, valid, and reliable measurement instrument used to evaluate pain severity. It was designed by Huskisson to quantify values that could not be measured in numbers. The most important advantage of the test is the lack of a language barrier and simplicity of application. The definition of the parameter to be assessed is written at the two ends of a 10 cm line, and the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks (Kazak and Ozkaraman, 2021, Crichton, 2001).

  5 minutes

Secondary Outcomes (3)

• WHOQOL-BREF:

  5 minutes

• The Fatigue Scale

  5 minutes

• The Perceived Stress Scale

  3 minutes

Study Arms (2)

Group-I

EXPERIMENTAL

Group-1: Twenty-five adult patients with SCD will receive a designed exercise program of physical therapy for relief pain and improve sleep quality (experimental group). The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, 3 days per week for 6 weeks in addition to walking 30 minutes on the ground surface daily.

Other: Exercise training program

Group-II

NO INTERVENTION

Group-2: Twenty-five adult patients with SCD will participate as a control group they will not receive exercise program.

Interventions

Exercise training program OTHER

The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, 3 days per week for 6 weeks in addition to walking 30 minutes on the ground surface daily. 1. Diaphragmatic Breathing Exercises: Diaphragmatic breathing (DBRT) or abdominal deep breathing is an expansion of the abdominal area rather than the thoracic area when breathing. 2. Progressive Muscle Relaxation (PMR): The physical element includes the tensing and relaxing of all muscle groups over the face, arms, trunk (abdomen \& chest) and legs. 3. A combination of stretching, stabilization and strengthening exercises of the pelvic-lumbar region: 4. Walking exercise: Walking on the ground surface for 30 minutes every day.

Group-I

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SCD patient
• Their age from18 -55 years
• have no communication problems
• They able to perform the exercises

You may not qualify if:

• Their age less than 18
• They unable to do the exercises.
• They had communication problems

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

IAU

Dammam, Estern, Saudi Arabia

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Parasomnias; Fatigue

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; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alsayed Shanb, Phd

  Associate professor in CAMS in IABF university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To prevent human bias regarding to participants and outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ealshurafa

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 8, 2023
• Study Start: May 20, 2022
• Primary Completion: February 25, 2023
• Study Completion: March 25, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)