None listed
Conditions
Brief summary
The aim of this study is to assess whether exercise combined with advice is more effective than advice alone in reducing the incidence of lymphoedema following surgery for gynaecological cancer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to undergo inguinal or pelvic lymph node dissection for gynaecological cancer management at Monash Medical Centre, Moorabbin campus. Trial Details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undertake a lower limb exercise programme and receive advice about the prevention of lymphoedema. The exercise programme will be taught by a physiotherapist and then completed by the participant in their own home. The exercises will take 15 minutes to complete twice a day for a 3 month duration. A rubber exercise band will be required for some of the exercises and will be provided by the physiotherapist at no cost to the participant. Participants in the other group will receive advice only. this is provided by the physiotherapist in an education leaflet which details strategies for reducing the risk of triggering lymphoedema e.g. skin care, weight maintenance etc Participants will be assessed pre-operatively, at 1 month post-operatively, and then at 6 weeks after chemotherapy or radiotherapy or at 3 months if no adjuvant therapies are required. The assessments will involve measurements of lower limb volume and completion of a quality of life questionnaire
Interventions
The intervention in this study will be the provision of a lower limb exercise programme. The 6 exercises are designed to slowly pump the muscles which will help squeeze fluid up the leg. They will be taught by the same physiotherapist to all the participants. The programme starts and finishes with diaphragmatic breathing to stimulate the deep lymphatic system. abdominal muscle contractions are followed by gluteal contactions, quadriceps and hamstring contactions and then gastrocnemius contractions. each exercise is repeated 20 times. theraband resistance is used for each exercise except for the abdominal contractions. the exercises will be taught by a physiotherapist on an individual basis. exercises will be undertaken twice a day for the 3 month trial period. The exercises should take 15 minutes to complete in the patient's own home Each exercise will be repeated for 20 repetitions at intensity 13 on the Borg Rating of Perceived Exertion (RPE) The Borg Scale is a patient’s subjective measure of physical activity intensity level based on the physical sensations a person experiences during physical activity such as increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue (Borg, 1998). It is agreed that perceived exertion ratings between 12 to 14 on the Borg Scale suggests that physical activity is “somewhat hard” being performed at a moderate level of intensity. The exercises are graded level 1 (easier) or level 2 (harder)and commence day 1 after surgery with no hip movement for the first 48hours to reduce strain on the suture line in the early post-operative period. Patients can choose which exercise level suits them best to gain level 13 on the Borg Scale. Each participant will be provided with an exercise protocol sheet containing written and pictorial description of all the exercises to ensure they are replicated exactly. Each participant will have their exercise regime checked at every review appointment by the same physiotherapist that prescribed the regime to ensure consistency of technique between the participants. review appointments consist of 40 minute consultations with the physiotherapist at baseline, 1 month, 6 weeks after chemotherapy, 6 weeks after radiotherapy or at 3 months if no adjuvant therapies occur The intervention group will also receive current standard care. They will be provided with an education leaflet by the physiotherapist detailing strategies to reduce the risk of triggering lymphoedema. Ryan et al (2004) report that patients identified the initial trigger for lower limb lymphoedema and those that exacerbate LLL symptoms. Trigger factor avoidance includes:Skin care – avoiding trauma and injury to reduce infection risk. Avoiding limb constrictions – items that leave deep tissue indentations, Weight maintenance – including the promotion of general exercise to maintain weight and stimulate the lymphatic system, Travel – regular foot and leg exercises for prolonged travel. Compression garments for flights longer than 4 hours, Avoiding extremes of temperature – including saunas and steam rooms, Pre-existing medical condition control – hypertension, cardiac disease, diabetes, thyroid disease, kidney and liver disease. Pre-existing lower limb oedema may require compression therapy especially in those with occupations where prolonged sitting and standing Written informed consent will be gained from each participant adherance will be monitored by an exercise partcipation diary completed by the patient
Sponsors
Study design
Eligibility
Inclusion criteria
inguinal or pelvic lymph node dissection for gynaecological cancer management at Monash Medical Centre, Moorabbin campus. English speaking or interpreter available Able to provide informed consent Able to attend regular follow up Able undertake a lower limb exercise programme
Exclusion criteria
Are found to have premorbid disease causing pre-operative oedema e.g. severe varicose veins, DVT Have metastatic or systemic disease Have had previous inguinal or pelvic node dissections Have any medical problem preventing them from undertaking the lower limb exercise programme e.g. severe joint pain preventing movement Have cognitive impairment based on stated history in their medical record