الفهرس 
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Abstract
Peripheral artery disease is one of the manifestations of generalized atherosclerotic disease which is characterized by a partial or complete failure of the arterial system to supply the peripheral tissue with oxygenated blood (Bailey et al., 2014; Smith et al., 2019). While early stages of PAD may be asymptomatic, the hallmarks of its most severe stage, known as critical limb ischemia, are recurrent lower limb rest pain, ulceration, and gangrene as well as an increased risk of cardiovascular events, amputation, and death. CLI is a limb-threatening condition whose prevalence has been estimated at 20 000 cases per year with an annual incidence of 40 per 100 000 population (Norgren et al., 2007). PAD is associated with limited physical capacity and impaired FS (Regensteiner et al., 2008). Because of pain, patients often avoid PA, especially ambulation, which leads to an additional decline in the FS (Mays et al., 2011).
Clinical trials have demonstrated that treadmill-based SET is beneficial in improving walking ability and to be effective in patients with PAD both with and without classic symptoms of claudication (Treat-Jacobson et al., 2019). It is recommended as an initial treatment for PAD and IC before any endovascular or open revascularization. Additionally, CLI and lifestyle-limiting claudication can be treated with an endovascular intervention vascular surgery (Aboyans et al., 2017; Gerhard-Herman et al., 2017; Norgren et al., 2007).
Several barriers including the insufficiency of centers and physician referral, high transportation cost, and scarce coverage of medical insurance, restrict the PAD patients from participating in SET (Li et al., 2015; Makris et al., 2012; Mays et al., 2013; Prévost et al., 2015; Regensteiner, 2004). Home-based walking exercise (H-BEx) is a promising alternative to SET (McDermott et al., 2013). Patients who are unable or unwilling to participate in SET may choose structured home exercise (SHE), which is effective in patients with PAD (Gerhard-Herman et al., 2017; Treat-Jacobson et al., 2019). However, the role of the SHE program after LE bypass has not been adequately studied. Therefore, the aim of this study is to assess the effect of physical rehabilitation on the patient’s FS after LE bypass surgery.
Research hypothesis: Patients undergoing arterial bypass surgery of the lower extremities who participate in the physical rehabilitation program exhibit high functional performance than those who do not.
Materials and Method:
Study design, setting, and participants: this controlled clinical trial was conducted at the vascular surgery department and the vascular surgery outpatient clinic at Alexandria Main University Hospital. A convenience sample of 40 patients who were planned for LE bypass surgery was recruited and assigned to two equal groups (rehabilitation group and control group).
Data collection tools: Data was collected using two tools, tool 1 ” Socio-demographic characteristics and biomedical data interview schedule for patients undergoing lower extremities arterial bypass surgery” was developed by the researcher after a review of the related literature. It gathered data about the patients’ socio-demographic characteristics (age, gender, marital status, educational level, employment status, financial condition and residence area, and living environment) and clinical data (the associated comorbid conditions and PAD risk factors and the present and the past history of the current illness).
Tool 2 ”The Walking Impairment Questionnaire (WIQ)” was first developed by Regenstiener et.al (1990). The English translation of the French version of the WIQ adapted by Mahe et al (2011) was used in this study. This tool contained 14 items that contributed to 3 subscales (distance, speed, and stair climbing). Each subscale assesses the degree of difficulty for performing the task (Gardner et al., 2006; Mays et al., 2011; Regensteiner et al., 1996; Treat-Jacobson et al., 2019). This tool was translated into the Arabic language.
The tools were submitted to five experts from the Faculty of Nursing, Alexandria University to review and test content validity and modifications were done based on their suggestions. The WIQ was tested for its reliability using Cronbach’s coefficient Alpha test, the reliability coefficient was (0.939) which is highly acceptable.
Data collection: data was collected for a period of 7 months started from July 2019 to January 2020. In the preoperative period; socio-demographic characteristics and biomedical data were collected using tool 1 and the baseline FS was assessed using tool 2 from all the study participants. The day before the surgery, patients in the rehabilitation group were educated about the postoperative exercises and instructions included in the rehabilitation program.
In the postoperative period; the control group was exposed only to the routine postoperative hospital care in the ward by the hospital staff. While the rehabilitation group received two phases of physical rehabilitation; an in-patient phase-1 and structured home-based phase-2 physical rehabilitation. The in-patient phase was started after the surgery until the patient’s discharge with an average of 5 days. During this phase, diaphragmatic breathing, foot and leg range of motion exercises, and light resistance exercises were used. Patients were encouraged for early ambulation, walking, and stair climbing training. During this phase, a second education session was held to given patients instructions regarding the use of assistive devices, weight-bearing status, and restricted activities.
Before the patient’s discharge; an education session was held to educate the patient about the structured 12 weeks phase-2 home-based walking exercise program. Patients were instructed to walk 3 to 5 days/ week. Each walking session consisted of a 5–10 min warm-up, walking, and a 5–10 minutes cool-down. Patients were instructed to start intermittent walking with at least 10 min/ day and progressively increased at least by 5 minutes weekly until a total of 45 minutes of walking was achieved. The walking intensity was established between 5-6/10 of the borg rating of perceived exertion (RPE) scale. Walking was stopped with heavy exertion (RPE=7) and the patient had a rest and then walking was continued to the target duration.
A booklet containing the content of the program that was designed by the researcher and written in a simple Arabic language and supplemented by photos and illustrations was used throughout the rehabilitation process and given to the patient. The FS of each patient in the control and rehabilitation group was assessed at 12 weeks of follow-up using tool 2. Patients who did not attend at the time were phone called and a second appointment was made.
Data processing and statistical analysis: after data collection, data were fed to the computer and analyzed using IBM- (SPSS) software version 25.0 (Armonk, NY: IBM Corp). Ethical considerations: these included obtaining approval from the ethical committee, Faculty of Nursing, Alexandria University, and written informed consent from the study participants. Also, patients’ privacy and data confidentiality was assured. Patients’ right to withdraw at any time of research participation was considered and respected.
Main results of the study:
Regarding the socio-demographic characteristics of the study participants; the study included 40 patients the majority of them were male (92.5%), more than half of them (55%) were more than 60 years old. The participants reported that 67.5% were married, 45 % had a sedentary occupation, and 60% reported that they live in the urban. 45% reported they live between the first and the third floor, half of the participants used stairs and the majority (90%) were living with others.
Regarding the associated comorbid conditions and PAD risk factors of the study participants; the results revealed that (47%), (35%), (27.5%) of the study participants had a history of hypertension, cardiovascular disease, and hyperlipidemia respectively. Also, being active smokers, overweight, or had diabetes mellitus was reported by half of the participants.
Regarding the past history of the current illness, less than half (42.5%) had the vascular condition for 12-36 months. In respect of the previous treatment for the vascular condition, the highest percent (82.5%) did not participate in lifestyle modification and cardiovascular risk reduction; in contrast, 77.5% of the participants received pharmacological treatment. The minority (15%) and (2.5%) had previous endovascular revascularization and surgical revascularization respectively. Additionally, a minority (2.5%) of them participated in exercise rehabilitation previously and/ or had previous toe(s) amputation, while 10% of them did not receive any previous treatments.
Regarding the present history of the current illness, the results revealed that all participants were diagnosed with CLI, the majority (87.5%) of them had femoropopliteal bypass surgery. Also, in the majority (87%) the surgery took 180-240 minutes. More than half (52.5%) of them had end to side anastomosis, with about two-thirds (65%) of the participants had synthetic graft. Moreover, the results showed that there were no statistically significant differences between both groups regarding all items of the socio-demographic characteristics and clinical data present history of the current illness.
Regarding the intergroup comparison of the FS; the results revealed that there were no statistically significant differences between the rehabilitation group and the control group in the WIQ total score and it’s domains (walking distance, walking speed, and stair climbing) (all p>0.05), while the differences of posttest scores were significant in favor of the rehabilitation group) (all p<0.05).
Regarding the intragroup comparison of the FS of the rehabilitation group, there was statistically significant difference between the pretest (Mean ± SD= 21.62 ± 10.75) and posttest (Mean ± SD = 64.22 ± 12.37) of the total WIQ mean percent scores (t=28.344, p <0.001). Moreover, there were significant differences (Z=3.922, p<0.001), (Z=3.925, p<0.001), (t=16.548, p<0.001) between the pretest and posttest of walking distance, walking speed, and stairs climbing percent scores respectively.
Regarding the intragroup comparison of the FS of the control group there was a statistically significant difference between pretest (Mean ± SD= 21.74 ± 9.90) and posttest (Mean ± SD = 49.24 ± 10.48) of the total walking impairment percent score (t=13.035, p <0.001). Moreover, there were statistically significant differences (Z=3.920, p<0.001), (Z=3.832, p<0.001), (t=14.166, p<0.001) between the pretest and posttest of walking distance, walking speed and stairs climbing percent scores respectively.
Moreover, there were no statistically significant differences (all p>0.05) within the rehabilitation group and the control group in the post-test FS mean scores percent concerning the socio-demographic characteristics and clinical data except for the significant difference found in the rehabilitation group concerning the history of previous surgical revascularization (p=0.012).
Conclusion and recommendations:
The study concluded that both revascularization alone and revascularization combined with a physical rehabilitation program improved FS measured by the WIQ for patients with CLI. However, those patients who participated in the physical rehabilitation program achieved better FS as compared to those who did not. These results may be promising for those patients to restore their walking performance.
Based on the finding of the study, the following recommendations are suggested:
- Integrate the physical rehabilitation program into the comprehensive management after LE bypass surgery for CLI.
- The program should be considered when updating the clinical guidelines.
- The health care team managing patients undergoing LE bypass should incorporate a rehabilitation nurse or physical therapist to help patients to reach their best function and health, and to adapt to an altered lifestyle.
- The inpatient department should be supplied with a physician handout that contains LE bypass management plan and that highlights and meets the rehabilitation needs of those patients.
- Moreover, a patient handout that illustrates the postoperative rehabilitation program should be accessible to patients.
- A mechanism to follow up on the patient’s progress and health outcomes should be developed, announced, and implemented.
- Further large-scale studies are required to verify our promising results.
- A comparative clinical trial to compare the outcome of this physical rehabilitation program (SHE) with other forms of exercises that have been proven as effective for PAD (e.g SET, resistance training, ……).
- The effect of the program on the patients’ physiological function should be evaluated.
- Patient compliance with the rehabilitation program and the factors affecting their compliance should be explored.