Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-17
Brief Title:
The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema
Sponsor:
Kayseri City Hospital
Organization:
Kayseri City Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hospitals 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 andor 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 patients 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 patients 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
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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None