Efficacy of Designed Exercise Program on Pain and Quality of Sleeping in Patient With Sickle Cell Disease Anemia.
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

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.
    

Detailed description: 
      Methodology:

      Design: Randomized clinical trial (RCT). Subjects' criteria: Fifty adult sickle cell disease
      patients who are aged more than 18 years with different socio-economic and educational
      levels. Patients with sickle cell anemia will be distributed into two groups. All personal
      data will be collected.

      Group-1: Twenty-five adult patents with SCD will receive a designed exercise program of
      physical therapy for relief pain and improve sleeping 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.

      Assessment instruments:

        1. 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).

        2. WHOQOL-BREF: The World Health Organization (WHO) identified Quality of Life (QoL) as "an
           individual's perception of his or her position in life, within the context of the
           culture and value systems in which they live, and in regard to his or her goals,
           expectations, standards and concerns" . QoL is consist of multiple aspects, including
           psychological health, physical well-being, social relationships, and environmental
           conditions. Although health professionals are trained on attending to these aspects
           during studies, own QoL might decline during the years in medical schools(Bani-Issa,
           2011).

        3. 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).

      4 - The Fatigue Scale: The fatigue scale, established by Chalder etal., is choosing to study
      the incidence of fatigue. The scale contains 11 questions, seven physical and four mental
      fatigue items. Patients will be asked if they had suffered each symptom in the last two weeks
      and the scale will be scored using a bimodal response system (0,0,1,1). the fatigue score
      will be calculated by adding together all the item scores (maximum score 11) and the total of
      four or more constituted a case of fatigue (Mcllvenny, 1999).

      5 - The Perceived Stress Scale: The (PPS) has been designed to measure the degree to which
      situations in a person's life are perceived as stressful. The PSS assesses the level of
      perceived stress experienced over the previous month, and has three versions: the PSS-14,
      PSS-10 and PSS-4 with 14 and 10 and 4 items respectively. The PSS-14 has seven positive and
      seven negative items. The Arabic version Perceived Stress Scale showed an adequate
      reliability and validity. Therefore, the Arabic Perceived Stress Scale is considered a
      suitable instrument to assess perceived stress in Arabic people (Almadi et al., 2012).

      Randomization type is blocking randomization. It will be taken by the main researcher using a
      random number generator by computer program software
      http://mahmoodsaghaei.tripod.com/Softwares/randalloc.html#Generate.

      Ethical approval: It will be obtained from the Institutional Review Board (IRB) at Imam
      Abdulrahman Bin Faisal University.

      Confidentiality: All data of participants will be saved in a personal computer locked with a
      password. All questionnaires' papers will be kept with the main researcher in a locker.

      Patient's rights: All recruited patients will sign a consent form before their participation,
      and they will be informed that the collected data will be published.

      Inclusion criteria: SCD patient, aged < 18 years, have no communication problems, did not
      regularly perform relaxation exercises, and able to perform the exercises.

      Exclusion criteria: Patients with SCD who are aged less than 18, unable to do the exercises
      and had communication problems.

      Procedures of the study:

      Fifty adult patients with SCD, will be randomly assigned to either experimental or control
      group. All patients will receive face-to-face instructions and explanations about the
      procedure of the study and assessment tools. The training period will take 6 weeks (details
      pertaining to the program which will be specified below) and the post-test including the same
      measures of the VAS, PSQI, WHOQOL-BREF, The Fatigue Scale and The PSS at the end of the
      6-week program.

      Group-I: Every patient will practice on exercise program for 30 to 45 minutes day other day
      for 6 weeks. All patients in the first group will participate as experimental group who will
      receive a designed exercise program of physical therapy for relief pain and improve sleep
      quality. They will be provided with a manual containing the necessary guidelines of the
      exercises and instructions to train from 30 to 45 minutes in addition to walking 30 minutes
      daily on the ground surface for 3 days per week for 6 weeks. The pre and post measurements
      will be done for all patients.

      Group-II: All patients of the second group will participate as a control group, they will not
      participate in the exercise program but the pre and post measurements will be done for all
      patients.

      Interventions:

      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.

        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. Diaphragmatic breathing is a manipulation of breath movement that contributes
           to a physiological response(Jerath et al., 2006). The benefits of DBRT have been
           demonstrated by Stromberg et al. (Stromberg et al., 2015) and Aslan et al. (Aslan et
           al., 2016). They explained that DBRT is an effective non-pharmacological treatment for
           improving sleep and emotions, resulting in diminished levels of anxiety, depression, and
           stress. And deep breathing has been shown to cause cardiopulmonary synchronization,
           resulting in stronger sympathetic inhibition. In contrast, fast or irregular breathing
           can lead to sympathetic excitation(Liu et al., 2021).

        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. In
           a sequential pattern, with eyes closed. Every patient places a tension in each muscle
           group purposefully for approximately 10 seconds and then relaxes it for 20 seconds
           before continuing with the next muscle group. The mental element involves that the
           individual concentrates on the distinction between the feelings of the tension and
           relaxation. Every patient with practice learns how to successfully relax in a short
           period of time. Relaxation must be attempted to reduce pain or pain perception and
           tension, create a pleasant mental state. The exercise will be performed in an average of
           30 minutes. The PMR sessions will be performed in a comfortable armchair(Benson et al.,
           1974, Örsal et al., 2014).

        3. A combination of stretching, stabilization and strengthening exercises of the
           pelvic-lumbar region: The exercises will be performed 3 times a week, three repetitions
           for 30 seconds:

           Exercise 1 - Unilateral flexion of the lower limbs over the abdomen:

           Aim: Bilateral stretching of one side of the lower quarters and for the upper quarter of
           the opposite side (lumbo-pelvic region), time: 30 seconds, repetitions: 3.

           Exercise 2 - Lower limb flexion over the abdomen:

           Aim: Stretching and stabilization of the lumbo-pelvic region, time: 30 seconds,
           repetitions: 3.

           Exercise 3 - Knee Roll:

           Aim: Strengthens medial rotators (tensor fascia lata muscle, gluteus minimus and gluteus
           medius and laterals -pyriform, femoral quadrate, internal and external obturators,
           superior and inferior gemelli) of the hip, time: 30 seconds, repetitions: 3.

           Exercise 4 - Bridge:

           Aims: Improves gluteus strength and strength of the muscles in the posterior thigh;
           Stretching of the flexor muscles of the hip (ilio-psoas and quadriceps); Improves
           lumbo-pelvic stability (torso and hips); Improves backbone mobility, time: 30 seconds
           repetitions: 3.

           Exercise 5 - Hyperextension of the hip moving against gravity:

           Aim: Strengthening of the extensor muscles of the hip (muscles of the gluteal regions
           and of the posterior thigh), time: 30 seconds, repetitions: 3 (Zanoni et al., 2021).

        4. Walking exercise: Walking on the ground surface for 30 minutes every day. Group-2:
           Twenty-five adult patients with SCD will participate as a control group they will not
           receive exercise program.

      Statistical analysis: the T-test and repeated measure analysis of ANOVA will be used to
      compare mean values within and between two groups. Results will be significant at P-value <
      0.05 and confidence interval at 0.95 %.
    

Intervention name(s): Exercise training program
Intervention type(s): Other
Intervention description(s): 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.
Diaphragmatic Breathing Exercises: Diaphragmatic breathing (DBRT) or abdominal deep breathing is an expansion of the abdominal area rather than the thoracic area when breathing.
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.
A combination of stretching, stabilization and strengthening exercises of the pelvic-lumbar region:
Walking exercise: Walking on the ground surface for 30 minutes every day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep disturbance; Fatigue; Stress; Quality of life