Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05894161 |
| Other study ID # |
IRB-UGS-2022-03-186 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2022 |
| Est. completion date |
March 25, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Imam Abdulrahman Bin Faisal University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 %.
