High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema

NCT ID: NCT05650372

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-02-07

Brief Summary

Lymphedema results from impaired lymphatic transport with increased limb volume. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant gains in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is to examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).

Detailed Description

Lymphedema results from impaired lymphatic transport with increased limb volume.

Lymphedema is divided into primary and secondary forms. Secondary lymphedema is likely to occur after the surgical removal of lymph nodes or in conjunction with radiotherapy. Secondary lymphedema is generally described as arm swelling and dysfunction. It is defined as an increase in arm circumference by more than 2 cm or as an accumulation of excessive protein-rich liquid in a part of the body where lymphatic vessels have been damaged. Erysipelas (cellulitis) is the main complication, but psychological or functional discomfort may occur throughout the course of lymphedema. The associated swelling may range from mild to disabling and is associated with feelings of distress, heaviness, and weakness in the arm, pain, and an increased risk for infection. These symptoms further impair the functional and self-care abilities of the individuals, causing significant psychological distress and reduced quality of life. Upper-limb lymphedema secondary to breast cancer treatment is the most frequent. Lymphedema management is based on complete decongestive physiotherapy (multilayer low-stretch bandage, manual lymph drainage, skincare, and exercises). The American college of sports medicine (ACSM) roundtable on exercise guidelines for cancer survivors describes that exercise during and after cancer treatment is safe and can help patients improve their physical capacity and quality of life. The ACSM guidelines indicate specific exercise programs oriented towards impairments associated with disease and medical treatment. Strength exercise does not have any adverse effects on an existing to; instead, it has beneficial effects such as improvement of strength and lower exacerbation rates. For breast cancer survivors who develop lymphedema, resistance exercise has been demonstrated to improve symptom severity, strength, endurance, and mobility of the affected limb, without exacerbating lymphedema. Recent evidence indicates that resistance exercise training can be an effective management strategy for breast cancer-related lymphedema by improving functional capacity and lymph flow through the pumping effect stimulated by muscular contraction. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant improvements in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).

Conditions

Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High intensity resistive exercise group

Participants of this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition.

Group Type: EXPERIMENTAL

High intensity resistive exercise

Intervention Type: OTHER

Participants of this group will be applied manual lymphatic drainage and compression bandaging every day of the week, and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition, 2 days of the week. Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises.Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull-down, bicep curl, triceps extension, lateral raise, and wrist curl.

Low intensity resistive exercise group

Participants in this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition.

Group Type: ACTIVE_COMPARATOR

Low intensity resistive exercise

Intervention Type: OTHER

participants in this group will be applied manual lymphatic drainage and compression bandaging every day of the week and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition 2 days of the week.

Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises. Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull- down, bicep curl, triceps extension, lateral raise, and wrist curl.

Interventions

High intensity resistive exercise

Participants of this group will be applied manual lymphatic drainage and compression bandaging every day of the week, and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition, 2 days of the week. Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises.Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull-down, bicep curl, triceps extension, lateral raise, and wrist curl.

Intervention Type: OTHER

Low intensity resistive exercise

participants in this group will be applied manual lymphatic drainage and compression bandaging every day of the week and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition 2 days of the week.

Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises. Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull- down, bicep curl, triceps extension, lateral raise, and wrist curl.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having been diagnosed with lymphedema of the upper extremity at least 6 months ago by the physician
• Having stage 2 lymphedema
• Having a circumference difference of 2-8 cm at any reference point between the affected extremity and the healthy extremity
• Being between the ages of 35-60
• Volunteer to participate
• Not receiving lymphedema treatment in the last 6 months

Exclusion Criteria

• Having stage 1 or 3 lymphedema
• Have a greater than 8 cm less than 2 cm circumference difference any reference point between the affected extremity and the healthy extremity
• Papilloma, lymphedema or elephanthiasis with hyperkeratosis
• Have acute inflammatory diseases

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: collaborator

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Buket AKINCI

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buket Akinci, PT, PhD

Role: STUDY_CHAIR

Biruni University

Locations

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2015-KAEK-64-22-09

Identifier Type: -

Identifier Source: org_study_id