Clinical trial NCT05650372: High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema
Official title: Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Resistive Exercises
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2022-12-14
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-blind study
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Arm circumference measurement
timeFrame: 1 month
Secondary outcomes:
measure: Measure of grip strength
timeFrame: 1 month
measure: Evaluation of pain (McGill Pain Questionnaire)
timeFrame: 1 month
measure: The disabilities of the arm, shoulder and hand (DASH) questionnaire
timeFrame: 1 month
measure: Lymphedema Life Impact Scale
timeFrame: 1 month
measure: Lymphedema Symptom Severity Scale
timeFrame: 1 month
measure: Pinch Strength Test
timeFrame: 1 month
measure: Lymphedema Functioning, Disability and Health Questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
affiliation: Biruni University
name: Buket Akinci, PT, PhD
role: STUDY_CHAIR
References: