Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema

NCT05609526 | Unknown

• 1 other identifier: IstanbulUC-AKGUL-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphedema of Leg; Lymphedema; Exercise

Keywords

Diagragma; Calf Muscle

Outcome Measures

Primary Outcomes (2)

• 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.

  5 minute

• 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.

  5 minute

Secondary Outcomes (3)

• Numerical Rating Scale

  5 minute

• 6-Minute Walk Test

  10minute

• Tissue Dielectric Constant (TDC)

  5 minute

Study Arms (4)

1.Group (Compression Therapy)

NO INTERVENTION

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.

2.Group (Inspiratory muscle training)

EXPERIMENTAL

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.

Other: Compression Therapy; Other: Inspiratory muscle training

3.Group (Calf muscle exercise training)

EXPERIMENTAL

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)

Other: Compression Therapy; Other: Calf muscle exercise training

4.Group (Inspiratory and calf muscle training)

EXPERIMENTAL

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

Other: Compression Therapy; Other: Inspiratory muscle training; Other: Calf muscle exercise training

Interventions

Compression Therapy OTHER

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.

2.Group (Inspiratory muscle training); 3.Group (Calf muscle exercise training); 4.Group (Inspiratory and calf muscle training)

Inspiratory muscle training OTHER

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.

2.Group (Inspiratory muscle training); 4.Group (Inspiratory and calf muscle training)

Calf muscle exercise training OTHER

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.

3.Group (Calf muscle exercise training); 4.Group (Inspiratory and calf muscle training)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with lymphedema
• No visual or hearing impairment
• Being literate in Turkish
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Related Publications (11)

• 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.

  PMID: 12444879 BACKGROUND

• Kocak Z, Overgaard J. Risk factors of arm lymphedema in breast cancer patients. Acta Oncol. 2000;39(3):389-92. doi: 10.1080/028418600750013168.

  PMID: 10987236 BACKGROUND

• 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.

  PMID: 12543727 BACKGROUND

• 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.

  PMID: 18519964 BACKGROUND

• 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.

  PMID: 3346962 BACKGROUND

• Szuba A, Rockson SG. Lymphedema: anatomy, physiology and pathogenesis. Vasc Med. 1997 Nov;2(4):321-6. doi: 10.1177/1358863X9700200408.

  PMID: 9575606 BACKGROUND

• 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.

  PMID: 35710091 BACKGROUND

• 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.

  PMID: 27164764 BACKGROUND

• 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.

  PMID: 19057479 BACKGROUND

• 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.

  PMID: 33322476 BACKGROUND

• Akgul A, Mazi I, Aydin G, Yavuz M, Yeldan I. The effect of muscles in the treatment of lower limb lymphedema: respiratory muscles or leg muscles? Support Care Cancer. 2025 Apr 11;33(5):375. doi: 10.1007/s00520-025-09436-3.

  PMID: 40214771 DERIVED

MeSH Terms

Conditions

Lymphedema; Motor Activity

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Study Officials

• Ahmet Akgül

  dean at university

  STUDY DIRECTOR

Central Study Contacts

İLKNUR MAZI

CONTACT

+90 541 731 92 32; mazilknur@gmail.com

mümine yavuz

CONTACT

+90 553 638 28 93; mumineyvz25@hotmail.çom

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 14, 2022
• Primary Completion: June 10, 2023
• Study Completion: September 12, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share