LymphedemaNCT05650372
High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema
A study testing High intensity resistive exercise and Low intensity resistive exercise in people with Lymphedema, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- What is being tested?
- High intensity resistive exercise and Low intensity resistive exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema
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).
Read the 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
- Being tested
- High intensity resistive exercise, Low intensity resistive exercise
- Keywords
- Lymphedema, Resistive Exercises
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity resistive exerciseOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low intensity resistive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (7)
Measure of grip strength
Grip strength on the affected extremity will be measured with a jamar dynamometer.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Lymphedema Symptom Severity Scale
The subjective feeling of heaviness, swelling, and tension intensity will be measured using a visual analog scale.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Nov 2022
- Primary completion1 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akinci, PT, PhD, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650372
- Sponsor's protocol ID
- 2015-KAEK-64-22-09
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT05650372
- Acronym / sponsor ID
- 2015-KAEK-64-22-09
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Resistive Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind study
| Arm | Type | Receives |
|---|---|---|
| High intensity resistive exercise group | Experimental | Other: High intensity resistive exerciseParticipants 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. |
| Low intensity resistive exercise group | Active comparator | Other: Low intensity resistive exerciseParticipants 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity resistive exerciseParticipants 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. | Other | High intensity resistive exercise group |
| Low intensity resistive exerciseparticipants 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. | Other | Low intensity resistive exercise group |
Primary outcome
Arm circumference measurement
Time frame: 1 month
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.
7 secondary outcomes
Measure of grip strength
Time frame: 1 month
Evaluation of pain (McGill Pain Questionnaire)
Time frame: 1 month
The disabilities of the arm, shoulder and hand (DASH) questionnaire
Time frame: 1 month
Lymphedema Life Impact Scale
Time frame: 1 month
Lymphedema Symptom Severity Scale
Time frame: 1 month
Pinch Strength Test
Time frame: 1 month
Lymphedema Functioning, Disability and Health Questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
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Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
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A Prospective Natural History Study of Lymphatic Anomalies
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Use of Reconstructive Microsurgery for the Treatment of Lymphedema
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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket Akinci, PT, PhD study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity resistive exercise and Low intensity resistive exercise in people with Lymphedema, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm circumference measurement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.