The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, a Randomized Control Trial (RCT)
Phase: NA
Conditions: Mastectomy; Lymphedema
Sponsor: American University of Beirut Medical Center

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The impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in 
Women after a Mastectomy, a RCT. 
June 30, 2018 
Submitted November 27, 2019 
 
 

Protocol: The Institution Review Board (IRB) of the university and the medical center granted approval for 
the study. Seventy-six women were approached while waiting for their surgery after approval form their 
surgeon. Women who showed interest in participating signed a consent form and were then randomly 
assigned to one of two groups by flipping a coin. Thirty women ended up in the intervention group and 
30 in the control group. Figure one details the protocol of the study. The intervention group received pre-
surgery education and training on therapeutic exercises in addition to the routine hospital care. The 
control group, which had 30 patients, received the routine hospital care that did not include any exercise 
training or education. Routine hospital care included explanation by the surgeon on the surgical procedure 
with follow up at two and four weeks after discharge.  The educational material was developed by the 
principal investigator (PI) and included a power point and a booklet with instructions on the exercises as 
well as information about the surgery and what to expect after the surgery. The educational material was 
based on previous research and adopted to our population after consultation with a panel of experts 
including two nurses and three physicians.  Eligible women were approached while waiting for their 
appointment with their surgeon. If they showed interest in participating they signed a consent form. The 
PI explained the study and what is involved in participating including the weekly phone calls for women 
in the intervention group. Participants were told that they will visited at home by the PI to assess their 
ROM and to fill out a questionnaire.   
The intervention: The intervention consisted of three phases. Phase 1 took place the day prior to surgery 
at which time the intervention and control, groups completed the QoL-BC survey and shoulder ROM was 
measured using the goniometer. Phase 2 consisted of one to one education with the intervention group 
prior to surgery. Education consisted of a power point presentation regarding the therapeutic exercises, 
information about the surgery and a booklet with pictures of the exercises to take home. In this phase 
demonstration of the exercises by the researcher with a return demonstration by the patient was done 
to ensure proper techniques. The researcher called the patients at home every week to ensure that the 
women were continuing the exercises. Phase 3 was conducted for both groups in the patient’s homes and 
entailed reassessment of shoulder ROM and completing the QoL-BC at the second and fourth week after 
discharge. All patients completed the study. The exercises included deep breathing as well as shoulder 
exercises such as extension of the triceps, biceps curl, paddling in sitting position, fluttering with both 
arms, hands behind neck, forward wall crawls, and side wall crawls.  
Patients were instructed to preform 10 repetitions of each exercise during hospitalization, with further 
guidance at the outpatient follow-up appointment. Shoulder flexion was limited to 90° of active assisted 

ROM for the first few days post-surgery and until the drains were removed, then gradually increased after 
the third postoperative day. Patients were instructed to keep performing the exercises after discharge.   
Results  
Patient characteristics   
There were no differences between groups at baseline. The majority of the patients in both groups were 
between 35 and 42 years of age, roughly 70% were married, and the majority of patients had a high school 
or higher education.   
Shoulder range of motion scores: While the shoulder ROM scores were not significantly different 
between groups prior to surgery, there were significant differences at the second and fourth weeks after 
surgery (Table 2). Flexion at two weeks for the intervention group was 133.80 ± 6.79 and for the control 
group it was 131.17 ± 2.20, p = 0.001, at four weeks it was 167.97 ± 4.09 for the intervention group and 
159.92 ± 1.73 for the control group, p < 0.001. Extension significantly improved for the study group at two 
weeks with a mean of 42.77 ± 2.30 versus 38.73 ± 1.46, p < 0.001 and at four weeks 53.07 ± 2.12 versus 
49.03 ± 1.25, p < 0.001. Additionally, abduction demonstrated a significant difference between the study 
and control groups at two weeks 143.50 ± 4.42 versus 138.57 ± 1.78, p < 0.001 and at four weeks 167.03 
± 4.61 versus 159.40 ± 1.69, p < 0.001.  
Differences between groups on each of the QoL-BC 4 subscales: There were no significant differences 
between groups at baseline on the QoL survey with both groups having low QoL scores. However, there 
were significant differences between groups at two and four weeks after surgery on the four subscales 
(Table 3). Physical well-being was significantly improved with the study group experiencing higher level of 
physical well-being than the control group; at two weeks, 58.37±6.16 versus 50.23±7.78, p = 0.001, and 
at four weeks 66.67 ± 6.19 versus 54.97 ± 9.55, p <0.001. For Psychological well-being there was significant 
difference between the two groups at two weeks, the study group mean 142.33 ± 15.48 and the control 
group 122.93±7.34, p <0.001, and at four weeks, 169.50 ±26.43 and 145.67 ± 12.44, p <0.001. Social well-
being at two weeks was significantly higher for the study group 43.57 ± 7.045 versus  29.30 ± 8.30 for the 
control group, p <0.001; and at four weeks 54.33 ± 8.73 for the study group versus 42.33 ± 5.08 for the 
control group, p <0.001. Spiritual well-being was significantly improved at two weeks, with a mean for the 
study group of 51.07 ± 4.37 versus 44.90 ± 6.05, p <0.001; and at four weeks 56.33 ± 3.96 versus 48.93 ± 
2.61, p <0.001.