Clinical trial NCT06327412: The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema
Official title: Effects of Hospital-Based Aerobic Exercise Therapy on Exercise Capacity, Body Composition, Functional Level and Quality of Life in Patients With Primary Lower Extremity Lymphedema; Prospective Randomized Controlled Single Blind Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Lymphedema
Aerobic Exercise
Keywords: primary lymphedema
aerobic execise
Cardiopulmonary Exercise Test
cardiopulmonary rehabilitation
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 35 patients with primary stage 2 and 3 lower extremity lymphedema, aged 18-65, who apply to the lymphedema outpatient clinic and meet the criteria of the International Society of Lymphology, will be included. Patients participating in the study will be randomized into 2 groups: aerobic exercise group (Group 1) and home exercise group (Group 2). According to randomization, 18 patients will be included in one group and 17 patients in the other.

Cardiopulmonary exercise test (CPET), 30-second-stand-sit test (30s-CST), 6-minute walk test (6MWT), Lymphedema Circumference and Volume Measurement, Bioimpedance Measurement, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale ( LLIC), Hospital Depression and Anxiety Scale (HADS), Numerical Rating Scale (NRS) forms will be filled in the cardiopulmonary rehabilitation unit of Kayseri City Hospital in the 0th, 4th and 16th weeks.
Primary purpose: TREATMENT

Brief summary: Our aim in this study is to evaluate the effects of lymphedema on exercise capacity, body composition, functional level and quality of life in lymphedema patients with primary lower extremity involvement.

Detailed description: Male and female patients aged 18-65, who applied to Kayseri City Hospital's Department of Physical Medicine and Rehabilitation (PMR), lymphedema outpatient clinic between September 2023 and September 2024 due to lower extremity edema, will be included in this study. Lymphedema was diagnosed by clinical and/or imaging methods (lower extremity circumference difference measurements, venous Doppler ultrasonography, lymphoscintigraphy), evaluated by an PMR specialist physician, phase 1 decongestive treatment was applied within the last month, stage 2-3 lower legs using Class 3 compression stockings were used. Patients with extremity lymphedema will be included. Our study is a prospective, randomized controlled, single-blind clinical trial. In our study, survey forms will be filled out by a researcher who is blind to the applied tests and study groups. Patients will be divided into 2 groups according to computerized randomization.

Demographic data such as age, gender, occupational status, education level, marital status of the patients whose verbal and written consent was obtained; Height, body weight, body mass index, smoking-alcohol use, medications used and additional diseases will be questioned and recorded in their files.

The lower extremity circumference of the patients will be measured with a flexible standard tape measure that is 150 cm long, 1 cm wide and spaced one cm apart. Measurements will be marked including the metatarsophalangeal joint, the middle of the dorsum of the foot, the ankle, and the end of the thigh at 4 cm intervals from this area. Circumference measurement from the marked points will be repeated twice each time by a physiatrist blinded to the study, and the average of the two measurements will be taken. These measurements will be repeated at the beginning of the study and at weeks 4 and 16.

The total extremity volume will be determined by calculating the data obtained from the circumference measurement with the Frustum formula, which is used to indirectly determine the extremity volume. The difference between both lower extremities before and after treatment will be determined. These evaluations will be repeated at the beginning of the study and at weeks 4 and 16.

The body extracellular fluid ratio will be determined by the bioelectrical impedance method using a body composition analyzer in which the impedance in the tissues is analyzed by applying a low level of electric current to the body. This measurement will be repeated at the beginning of the study and at weeks 4 and 16.

CPET test will be performed in patients to evaluate their aerobic exercise capacity. CPET tests will be applied with a device in the Cardiopulmonary Rehabilitation Unit of Kayseri City Hospital Physical Therapy and Rehabilitation Department. All patients will be informed about the exercise test before the test. Patients will undergo a detailed physical examination, height, body weight, body mass index, heart rate, blood pressure will be measured and evaluated by taking a baseline ECG. The change in the patient's exercise capacity will be evaluated at the 0th, 4th and 16th weeks according to the VO2 max (the maximum amount of oxygen that an individual can utilize during intense or maximal exercise) value in the CPET test. The CPET test and questionnaires administered to all patients who complete the treatment before treatment will be re-evaluated at the 4th and 16th weeks.

In Group 1 (Hospital-based aerobic exercise group), patients were given 40 minutes (5 minutes warm-up, 30 minutes exercise, 5 minutes exercise) for 4 weeks, 5 days a week, at an exercise intensity of 50-60% of the VO2 max level recorded individually in the patients according to the CPET test. Aerobic exercise therapy will be organized to be applied on a treadmill (in the form of a cooling down).

In Group 2 (Home-based exercise group), patients will be asked to walk 40 minutes a day, 5 days a week, for 4 weeks. Training will be given for the first session in the hospital to ensure that the patient's walking pace is between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg scale.

Both patient groups will be given lymphedema-specific remedial exercise program training. Anatolian Lymphedema Association lower extremity lymphedema exercise sheets will be delivered to the patients in writing, and training on exercise practices will be given face to face as a session by a physiotherapist at the physical therapy lymphedema outpatient clinic. Patients will be asked to perform these exercises daily as stated in the leaflet and in the number of repetitions. Patients will be given an exercise diary to ensure their compliance with exercise and will be asked to mark this form daily. In the home exercise group, treatment compliance will be increased by making weekly phone calls to patients in order to increase treatment compliance and evaluate compliance.

Before the treatment, at the end of the 4-week treatment and at the 16th week, the patients had 30-second sit-to-stand test (30s-CST), 6-minute walk test (6MWT), Circumference-volume and bioimpedance measurement, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact. Scale (LLIC), Hospital Depression and Anxiety scale (HADS), Numerical Rating Scale (NRS) forms will be filled out.

Eligibility criteria: Inclusion Criteria:

* Patients who have completed complete decongestive therapy (CBT) Phase 1 treatment within the last 1 month, use Class 3 compression garments, and are scheduled for CBT Phase 2 treatment.
* Patients with stage 2-3 unilateral or bilateral primary lymphedema with lower extremity involvement
* Women and men aged 18-65
* Patients who agreed to participate in the study and received written voluntary consent form.

Exclusion Criteria:

* Patients who do not agree to participate in the study
* Patients without cooperation and compliance
* Presence of phlebo edema, lipedema, cellulitis, lymphocele
* History of lower extremity venous system disease
* Presence of acute infection
* History of malignancy
* Presence of acute/chronic lung disease (history of acute pulmonary embolism, acute bronchial asthma attack, chronic interstitial lung disease)
* Chronic liver failure
* Renal dysfunction
* Uncontrolled hypertension and diabetes mellitus
* Presence of orthopedic disease that may prevent walking (joint limitation, ankylosis, amputation)
* Use of medications known to affect physical performance, heart rate or metabolism (including Beta blockers)
* Patients who have been included in the CPR (Cardiopulmonary resuscitation) program in the last year

Primary outcomes:
measure: 30-second sit-stand test (30-s chair-stand test, 30s-CST)
timeFrame: week 0, 4th week, 16th week
Secondary outcomes:
measure: Cardiopulmonary exercise test (CPET)
timeFrame: week 0, 4th week, 16th week
measure: 6-minute walk test (6MWT)
timeFrame: week 0, 4th week, 16th week
measure: Circumference and volume measurement
timeFrame: week 0, 4th week, 16th week
measure: Bioimpedance measurement
timeFrame: week 0, 4th week, 16th week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: week 0, 4th week, 16th week
measure: Lymphedema Life Impact Scale (LLIC)
timeFrame: week 0, 4th week, 16th week
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 0, 4th week, 16th week
measure: Numerical Rating Scale (NRS)
timeFrame: week 0, 4th week, 16th week
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Study officials:
affiliation: Kayseri City Hospital
name: Fatma Gül Ülkü Demir, MD
role: STUDY_DIRECTOR
affiliation: Health Sciences University, Kayseri Medical Faculty
name: Firdevs Akdeniz Çınar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30.
citation: Hamilton DM, Haennel RG. Validity and reliability of the 6-minute walk test in a cardiac rehabilitation population. J Cardiopulm Rehabil. 2000 May-Jun;20(3):156-64. doi: 10.1097/00008483-200005000-00003.
citation: Sakamoto M, Suematsu Y, Yano Y, Kaino K, Teshima R, Matsuda T, Fujita M, Tazawa R, Fujimi K, Miura SI. Depression and Anxiety Are Associated with Physical Performance in Patients Undergoing Cardiac Rehabilitation: A Retrospective Observational Study. J Cardiovasc Dev Dis. 2022 Jan 11;9(1):21. doi: 10.3390/jcdd9010021.
citation: Verbrugghe J, Agten A, Stevens S, Hansen D, Demoulin C, O Eijnde B, Vandenabeele F, Timmermans A. Exercise Intensity Matters in Chronic Nonspecific Low Back Pain Rehabilitation. Med Sci Sports Exerc. 2019 Dec;51(12):2434-2442. doi: 10.1249/MSS.0000000000002078.