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

Lymphedema Clinical Trial

Official title:

Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05650372
• Other study ID #: 2015-KAEK-64-22-09
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: February 2023
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 7, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Fatih

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm circumference measurement	Bilateral arm circumference will be measured using a measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle.	1 month
Secondary	Measure of grip strength	Grip strength on the affected extremity will be measured with a jamar dynamometer.	1 month
Secondary	Evaluation of pain (McGill Pain Questionnaire)	The mcgill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The questionnaire is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.	1 month
Secondary	The disabilities of the arm, shoulder and hand (DASH) questionnaire	Assess musculoskeletal disorders of the upper limbs will be measured this questionnaire.; The disabilities of the arm, shoulder, and hand questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.	1 month
Secondary	Lymphedema Life Impact Scale	Lymphedema Life Impact Scale was developed as a comprehensive,lymphedema-specific instrument to assess the effects of lymphedema on any extremity. The questionnaire is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.	1 month
Secondary	Lymphedema Symptom Severity Scale	The subjective feeling of heaviness, swelling, and tension intensity will be measured using a visual analog scale.	1 month
Secondary	Pinch Strength Test	This evaulation for measuring the maximum isometric strength of the hand and forearm muscles when doing a pinching action and pinch strength on the affected extremity will be measured with a pinch meter.	1 month
Secondary	Lymphedema Functioning, Disability and Health Questionnaire	The Lymphedema Functioning, Disability, and Health Questionnaire is a reliable and valid questionnaire to assess impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema after axillary dissection for breast cancer.	1 month