search
Back to results

Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema

Primary Purpose

Lymphedema of Leg, Lymphedema, Exercise

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compression Therapy
Inspiratory muscle training
Calf muscle exercise training
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Leg focused on measuring Diagragma, Calf Muscle

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Having been diagnosed with lymphedema No visual or hearing impairment Being literate in Turkish 18- 75 years old Exclusion Criteria: Acute infection Aardiac edema Peripheral arterial diseases Congestive advanced heart failure Malignant lymphedema Having a psychiatric disorder requiring prior vessel ablation and/or prescription medication Having a neurological, orthopedic or rheumatological disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    1.Group (Compression Therapy)

    2.Group (Inspiratory muscle training)

    3.Group (Calf muscle exercise training)

    4.Group (Inspiratory and calf muscle training)

    Arm Description

    The patient will be placed in the supine position. Short stretch bandages of 6, 8, 10 and 12 cm will be applied to the extremity in a multi-layered and special way. Starting with the finger bandage, the pressure will be reduced as it goes distally. The patient's gait and circulation will be checked after bandaging is finished. will be.

    Maximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time 30 minutes per day will be. On the first day, the MIP levels of the participants will be evaluated and the training workload will be determined as 30% of the MIP. For IMT, after a nose clip was inserted from the participants They will be asked to sit on the mouthpiece of the device and close their lips tightly. With the device in this position, the device for four to five breath rests after every 10 breathing cycles. mouth, and repeat the cycle for 15 minutes.

    A strengthening treatment program will be applied to the calf muscles. CMET will consist of static stretching exercise for the dorsiflexors and plantar flexors, isotonic resistance exercise with elastic resistance bands, heel and toe lift in both feet, followed by toe raising and lowering without heel raising. An isotonic exercise (mini squat) will be performed for ankle pumping exercise and knee flexion in sitting position. Patients will begin strength training with elastic resistance bands using red bands (lowest resistance). Green and blue bands by increasing the number of sets and repetitions will start to be used (increased resistance). (31.32)

    All applications made in 3 groups will be made in this group.

    Outcomes

    Primary Outcome Measures

    Lymphedema Quality of Life Scale
    Evaluates the effect of arm and leg edema on quality of life with separate questionnaires. It consists of 4 subscales: function, appearance, symptom and mood. The score of each item ranges from 1 to 4 (1 = not at all, 2 = a little, 3 = a lot, 4 = a lot). The score of each scale is calculated by dividing the total score by the number of items and ranges from 1 to 4. It is concluded that the higher the score, the more the quality of life is affected.
    Lower Extremity Perimeter Measurement
    It will be calculated using the Frustum Formula from circumference measurements taken at 10 cm intervals from the tip of the second toe to the thigh. Patients' affected and unaffected lower extremities will be measured with standard fiberglass. Measurements will be made by the same physiotherapist before and after the 4-week intervention.

    Secondary Outcome Measures

    Numerical Rating Scale
    Subjective feedback of patients regarding leg fullness associated with lymphedema will be recorded by the scoring method of the affected lower extremity. This scoring will be between 0 and 10.
    6-Minute Walk Test
    It is used to determine walking capacity by measuring the maximum distance an individual can walk in six minutes.
    Tissue Dielectric Constant (TDC)
    The tissue dielectric constant (TDC) technique gives information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin.

    Full Information

    First Posted
    November 1, 2022
    Last Updated
    November 16, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05609526
    Brief Title
    Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema
    Official Title
    Target Muscles Training in Patients With Leg Lymphedema : Inspiratory Muscles Versus Calf Muscles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 14, 2022 (Anticipated)
    Primary Completion Date
    June 10, 2023 (Anticipated)
    Study Completion Date
    September 12, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Lymphedema results in the accumulation of protein-rich fluid in the subcutaneous tissue as a result of the failure of the lymphatic system, which returns water and protein in the interstitial spaces to the bloodstream. The aim of its treatment is to return this fluid accumulated in the interstitial space to the venous system. Early diagnosis and subsequent treatment of lymphedema, which is a chronic and progressive problem, is important to improve symptoms and prevent complications. Exercises recommended by specialist physiotherapists increase lymph flow and improve protein resorption. Exercises applied with compression bandages or compression garments provide significant improvement in patients with lymphedema. The aim of this study is to provide inspiratory muscle training and leg compression therapy together with compression therapy in patients with lower extremity lymphedema. To evaluate the effectiveness of these exercises on the patient's extremity volume and fullness, tissue water content, edema status, walking capacity, functionality and quality of life by comparing the effectiveness of muscle exercise training. In addition, researchers aim to determine the more effective exercise method for these patients.
    Detailed Description
    Lymphedema is a chronic, progressive disease that occurs with the accumulation of protein-rich fluid in the interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Exercise is one of the components of Complex Relief Physiotherapy, which is used as the gold standard in the treatment of lymphedema. exercises put pressure on lymphatic vessels with rhythmic contraction and relaxation of muscle groups. Thus, smooth muscle contraction in the lymphatic vessels is triggered. The transport of lymph fluid is possible with the activation of the muscles that provide the movement of the skin. It has been shown that strengthening the calf muscle with exercise can improve the pumping function, increase the average peak torque of the muscle, decrease the severity of the disease, increase the ankle joint movement, increase the calf muscle endurance and improve the quality of life. The pump power of the inspiratory muscles is also important in the lymph circulation, as well as in the venous circulation. This study will include 45 patients who volunteered to participate in the study, who were treated at Istanbul University- Cerrahpasa Faculty of Health Sciences and Gerontology Research and Application Center from October 2022 to October 2023. Lymphedema Quality of Life Scale for Evaluation (LYQOL) Lower Extremity Perimeter Measurement Numerical Rating Scale . 6 Minute Walk Test. Tissue Dielectric Constant (TDC) will be used. Participants will be randomly divided into 4 groups. Only compression therapy(CT) will be given to the 1st group, inspiratory muscle training (IMT) in addition to the compression therapy to the 2nd group, and Calf muscle exercise training to the 3rd group in addition to CT. CT will be applied to the patients in all four groups for 45-60 minutes a day, 6 days a week, for 4 weeks. Patients in the other 2 groups will participate in an exercise program for 4 weeks, 4 days a week, in addition to CT. The power analysis will be calculated based on the 5% margin of error, 95% confidence level, using the Raosoft sample size and the clinically significant minimum difference of LYMQOL, one of the primary measurement tools.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema of Leg, Lymphedema, Exercise
    Keywords
    Diagragma, Calf Muscle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1.Group (Compression Therapy)
    Arm Type
    No Intervention
    Arm Description
    The patient will be placed in the supine position. Short stretch bandages of 6, 8, 10 and 12 cm will be applied to the extremity in a multi-layered and special way. Starting with the finger bandage, the pressure will be reduced as it goes distally. The patient's gait and circulation will be checked after bandaging is finished. will be.
    Arm Title
    2.Group (Inspiratory muscle training)
    Arm Type
    Experimental
    Arm Description
    Maximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time 30 minutes per day will be. On the first day, the MIP levels of the participants will be evaluated and the training workload will be determined as 30% of the MIP. For IMT, after a nose clip was inserted from the participants They will be asked to sit on the mouthpiece of the device and close their lips tightly. With the device in this position, the device for four to five breath rests after every 10 breathing cycles. mouth, and repeat the cycle for 15 minutes.
    Arm Title
    3.Group (Calf muscle exercise training)
    Arm Type
    Experimental
    Arm Description
    A strengthening treatment program will be applied to the calf muscles. CMET will consist of static stretching exercise for the dorsiflexors and plantar flexors, isotonic resistance exercise with elastic resistance bands, heel and toe lift in both feet, followed by toe raising and lowering without heel raising. An isotonic exercise (mini squat) will be performed for ankle pumping exercise and knee flexion in sitting position. Patients will begin strength training with elastic resistance bands using red bands (lowest resistance). Green and blue bands by increasing the number of sets and repetitions will start to be used (increased resistance). (31.32)
    Arm Title
    4.Group (Inspiratory and calf muscle training)
    Arm Type
    Experimental
    Arm Description
    All applications made in 3 groups will be made in this group.
    Intervention Type
    Other
    Intervention Name(s)
    Compression Therapy
    Intervention Description
    6, 8, 10 and 12 cm short tension bandages multi-layered and will be applied specifically to the extremity. Starting with the finger bandage, the pressure will be reduced as it goes distally.
    Intervention Type
    Other
    Intervention Name(s)
    Inspiratory muscle training
    Intervention Description
    Maximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time per day will be 30 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Calf muscle exercise training
    Intervention Description
    A strengthening treatment program will be applied to the calf muscles.dorsiflexors and plantar flexors will consist of static stretching exercise, isotonic resistance exercise with elastic resistance bands, heel and toe raising in both feet, followed by toe raising and lowering without raising the heel.
    Primary Outcome Measure Information:
    Title
    Lymphedema Quality of Life Scale
    Description
    Evaluates the effect of arm and leg edema on quality of life with separate questionnaires. It consists of 4 subscales: function, appearance, symptom and mood. The score of each item ranges from 1 to 4 (1 = not at all, 2 = a little, 3 = a lot, 4 = a lot). The score of each scale is calculated by dividing the total score by the number of items and ranges from 1 to 4. It is concluded that the higher the score, the more the quality of life is affected.
    Time Frame
    5 minute
    Title
    Lower Extremity Perimeter Measurement
    Description
    It will be calculated using the Frustum Formula from circumference measurements taken at 10 cm intervals from the tip of the second toe to the thigh. Patients' affected and unaffected lower extremities will be measured with standard fiberglass. Measurements will be made by the same physiotherapist before and after the 4-week intervention.
    Time Frame
    5 minute
    Secondary Outcome Measure Information:
    Title
    Numerical Rating Scale
    Description
    Subjective feedback of patients regarding leg fullness associated with lymphedema will be recorded by the scoring method of the affected lower extremity. This scoring will be between 0 and 10.
    Time Frame
    5 minute
    Title
    6-Minute Walk Test
    Description
    It is used to determine walking capacity by measuring the maximum distance an individual can walk in six minutes.
    Time Frame
    10minute
    Title
    Tissue Dielectric Constant (TDC)
    Description
    The tissue dielectric constant (TDC) technique gives information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin.
    Time Frame
    5 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Having been diagnosed with lymphedema No visual or hearing impairment Being literate in Turkish 18- 75 years old Exclusion Criteria: Acute infection Aardiac edema Peripheral arterial diseases Congestive advanced heart failure Malignant lymphedema Having a psychiatric disorder requiring prior vessel ablation and/or prescription medication Having a neurological, orthopedic or rheumatological disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    İLKNUR MAZI
    Phone
    +90 541 731 92 32
    Email
    mazilknur@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mümine yavuz
    Phone
    +90 553 638 28 93
    Email
    mumineyvz25@hotmail.çom
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmet Akgül
    Organizational Affiliation
    dean at university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12444879
    Citation
    Sander AP, Hajer NM, Hemenway K, Miller AC. Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. Phys Ther. 2002 Dec;82(12):1201-12.
    Results Reference
    background
    PubMed Identifier
    10987236
    Citation
    Kocak Z, Overgaard J. Risk factors of arm lymphedema in breast cancer patients. Acta Oncol. 2000;39(3):389-92. doi: 10.1080/028418600750013168.
    Results Reference
    background
    PubMed Identifier
    12543727
    Citation
    Gashev AA. Physiologic aspects of lymphatic contractile function: current perspectives. Ann N Y Acad Sci. 2002 Dec;979:178-87; discussion 188-96. doi: 10.1111/j.1749-6632.2002.tb04878.x.
    Results Reference
    background
    PubMed Identifier
    18519964
    Citation
    Olszewski WL. Contractility patterns of human leg lymphatics in various stages of obstructive lymphedema. Ann N Y Acad Sci. 2008;1131:110-8. doi: 10.1196/annals.1413.010.
    Results Reference
    background
    PubMed Identifier
    3346962
    Citation
    Browse NL. The pathogenesis of venous ulceration: a hypothesis. J Vasc Surg. 1988 Mar;7(3):468-72. doi: 10.1067/mva.1988.avs0070468. No abstract available.
    Results Reference
    background
    PubMed Identifier
    9575606
    Citation
    Szuba A, Rockson SG. Lymphedema: anatomy, physiology and pathogenesis. Vasc Med. 1997 Nov;2(4):321-6. doi: 10.1177/1358863X9700200408.
    Results Reference
    background
    PubMed Identifier
    35710091
    Citation
    Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
    Results Reference
    background
    PubMed Identifier
    27164764
    Citation
    Do JH, Kim W, Cho YK, Lee J, Song EJ, Chun YM, Jeon JY. EFFECTS OF RESISTANCE EXERCISES AND COMPLEX DECONGESTIVE THERAPY ON ARM FUNCTION AND MUSCULAR STRENGTH IN BREAST CANCER RELATED LYMPHEDEMA. Lymphology. 2015 Dec;48(4):184-96.
    Results Reference
    background
    PubMed Identifier
    19057479
    Citation
    Keeley V. Quality of life assessment tools in chronic oedema. Br J Community Nurs. 2008 Oct;13(10):S22-7. doi: 10.12968/bjcn.2008.13.Sup5.31193.
    Results Reference
    background
    PubMed Identifier
    33322476
    Citation
    Solari E, Marcozzi C, Negrini D, Moriondo A. Lymphatic Vessels and Their Surroundings: How Local Physical Factors Affect Lymph Flow. Biology (Basel). 2020 Dec 11;9(12):463. doi: 10.3390/biology9120463.
    Results Reference
    background

    Learn more about this trial

    Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema

    We'll reach out to this number within 24 hrs