The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema

NCT06327412 | Not Yet Recruiting

• 1 other identifier: KayseriCHLYMP01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Lymphedema; Aerobic Exercise

Keywords

primary lymphedema; aerobic execise; Cardiopulmonary Exercise Test; cardiopulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 30-second sit-stand test (30-s chair-stand test, 30s-CST)

  It is a test with proven validity and reliability that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The patient's sitting height is approximately 43 cm on a chair without arms; The patient is asked to sit with his back straight and straight, his arms crossed in front, his feet on the floor, and then he is asked to sit and stand within 30 seconds. The number of times he sits and stands gives the score of the test.

  week 0, 4th week, 16th week

Secondary Outcomes (8)

• Cardiopulmonary exercise test (CPET)

  week 0, 4th week, 16th week

• 6-minute walk test (6MWT)

  week 0, 4th week, 16th week

• Circumference and volume measurement

  week 0, 4th week, 16th week

• Bioimpedance measurement

  week 0, 4th week, 16th week

• Lower Extremity Functional Scale (LEFS)

  week 0, 4th week, 16th week

Study Arms (2)

Hospital Exercise Group

ACTIVE COMPARATOR

According to the Cardiopulmonary Exercise test (CPET), the patients should exercise on the treadmill (5 minutes warm-up, 30 minutes exercise, 5 minutes cool-down) for 40 minutes (5 minutes warm-up, 30 minutes exercise, 5 minutes cool-down) at an exercise intensity of 50-60% of the individually recorded VO2 max (the maximum amount of oxygen that an individual can utilize during intense or maximal exercise) level in the patients. Aerobic exercise therapy will be organized to include treadmill.

Other: Aerobic exercise on the treadmill

Home Exercise Group

PLACEBO COMPARATOR

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.

Other: Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale

Interventions

Aerobic exercise on the treadmill OTHER

According to the cardiopulmonary exercise (CPET) test, 40 minutes (5 minutes warm-up, 30 minutes exercise, 5 minutes cool-down) at an exercise intensity of 50-60% of the VO2 max (the maximum amount of oxygen that an individual can utilize during intense or maximal exercise) level recorded individually in patients, 5 days a week for 4 weeks.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

Hospital Exercise Group

Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale OTHER

He/she 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 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.Treatment compliance will be increased by making weekly phone calls to patients in order to increase treatment compliance and evaluate compliance.

Home Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28966333 BACKGROUND

• 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.

  PMID: 10860197 BACKGROUND

• 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.

  PMID: 35050231 BACKGROUND

• 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.

  PMID: 31269004 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Fatma Gül Ülkü Demir, MD

  Kayseri City Hospital

  STUDY DIRECTOR

• Firdevs Akdeniz Çınar

  Health Sciences University, Kayseri Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva Talay Çalış, Prof

CONTACT

+90532 687 45 41; htalaycalis@yahoo.com

Firdevs Akdeniz Çınar, MD

CONTACT

+905372541434; firdevs-akdeniz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)