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

NCT05650372 | Completed

• 1 other identifier: 2015-KAEK-64-22-09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphedema

Keywords

Lymphedema; Resistive Exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measure of grip strength

  1 month

• Evaluation of pain (McGill Pain Questionnaire)

  1 month

• The disabilities of the arm, shoulder and hand (DASH) questionnaire

  1 month

• Lymphedema Life Impact Scale

  1 month

• Lymphedema Symptom Severity Scale

  1 month

Study Arms (2)

High intensity resistive exercise group

EXPERIMENTAL

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.

Other: High intensity resistive exercise

Low intensity resistive exercise group

ACTIVE COMPARATOR

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.

Other: Low intensity resistive exercise

Interventions

High intensity resistive exercise 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.

High intensity resistive exercise group

Low intensity resistive exercise 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.

Low intensity resistive exercise group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead
• Istanbul University: collaborator

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Buket Akinci, PT, PhD

  Biruni University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to the randomization and the investigator will be blind to the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Randomized controlled single-blind study

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: November 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 7, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)