Effectiveness of a Therapeutic Exercise Program With Specific Upper Limb Exercises to Reduce Lymphedema and Neuropathy in Breast Cancer Patients: A Pre-post Study (LYNMA)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-70
SponsorUniversitat Internacional de Catalunya

About this trial

This study aims to evaluate the effectiveness of a therapeutic exercise program designed specifically for women with breast cancer. The program includes general exercises along with specific movements for the upper limb to help reduce common side effects of cancer treatment such as lymphedema (swelling of the arm) and neuropathy (nerve pain or numbness). Participants will undergo the exercise program and be assessed before and after to determine improvements in their symptoms and overall quality of life. The goal is to provide evidence that targeted physical therapy can improve recovery and well-being in breast cancer survivors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients receiving treatment for breast carcinoma.reatments include surgical procedures (breast-conserving surgery or mastectomy), axillary lymph node dissection, sentinel lymph node biopsy, radiotherapy, chemotherapy, and hormone therapy.

Participants must provide authorization from their primary care physician and/or oncologist to perform therapeutic exercise.

Diagnosis of lymphedema associated with stage I or II breast cancer (Stage 1 or mild: circumference difference less than 4 cm [volume difference 10-25%] compared to the healthy arm; Stage 2 or moderate: circumference difference between 4 and 6 cm [volume difference 25-50%] compared to the healthy arm).

A score of 4 or higher on the DN4 questionnaire (neuropathic pain)

Disqualifiers

Lack of medical authorization.

Pre-existing cardiac pathology prior to cancer diagnosis.

Exacerbation of comorbidities.

Travel time exceeding 45 minutes to the location where the therapeutic exercise program is conducted.

Trial design

Design model

Single group

Treatments tested in this trial

  • Therapeutic exercise

    Other intervention

    Participants will follow a 3-month therapeutic exercise program combining general exercises with specific upper limb exercises, including hand proprioception and neurodynamic techniques. Two group sessions per week (1 to 1.15 hours each) will be conducted, with at least 24 hours between sessions. Each session includes warm-up, three progressive work blocks with strength, mobility, and balance exercises, and a cool-down. Strength training uses body weight and equipment, with intensity guided by the Rate of Perceived Exertion (RPE) scale, progressing safely from moderate to higher levels. Mobility and balance exercises target trunk, upper and lower limbs, and postural control. Neurodynamic techniques focus on median, radial, and ulnar nerves using neural sliding and intermittent tension, stopping exercises if pain exceeds 4/10. Supervised by experienced physiotherapists, the program aims to reduce lymphedema and neuropathy symptoms in breast cancer patients undergoing cancer treatment.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Therapeutic exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Excess limb volume (%) compared to the unaffected limb

Excess volume of the affected limb (percentage compared to the unaffected limb). The volume of each limb will be measured manually using a measuring tape by taking circumferences every 4 centimeters from the wrist to the axilla. Limb volume will be calculated using the Kuhnke formula: Volume equals the sum of the squares of the circumferences (C1 squared plus C2 squared plus ... plus Cn squared) divided by pi, where C1, C2, … Cn are the circumferences measured at different points along the limb.

Time frame
Baseline (before intervention), Immediately post-program (Day 0 after completion)

Secondary outcomes

1

Change in neuropathic pain intensity measured with DN4 questionnaire

Will be assessed using the DN4 questionnaire, designed to help identify neuropathic pain. It is a simple, quick, and highly reliable tool widely used in clinical practice and research. The questionnaire consists of 10 items divided into two parts: a patient interview and a physical examination performed by the healthcare professional. Each item is scored as "yes" or "no," with each positive answer receiving 1 point. A total score of 4 or more is interpreted as indicative of neuropathic pain

Time frame
Baseline (before intervention), Immediately post-program (Day 0 after completion)
2

Change in hand grip strength from baseline measured with handheld dynamometer (kg)

Hand grip strength will be assessed using a digital hand dynamometer (BIMS). This test is an indicator of overall muscle strength and has been previously used as a marker of clinical and nutritional status, as well as a predictor of decreased functional capacity in breast cancer patients

Time frame
Baseline (before intervention), Immediately post-program (Day 0 after completion)
3

Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²)

Will be assessed using musculoskeletal ultrasound, a useful technique to evaluate possible signs of inflammation, entrapment, or neuropathy. Observed changes can provide relevant information about the presence of inflammation or compression. One common indicator is an increased cross-sectional area of the nerve (measured in mm), which may indicate intraneural edema or an inflammatory process. We will complement the assessment by comparing the affected nerve with the contralateral healthy side to detect differences that may be considered pathological.

Time frame
Baseline (before intervention), Immediately post-program (Day 0 after completion)
4

Change in upper limb function measured with QuickDASH questionnaire (score 0-100)

Upper limb function will be measured with the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire. This tool assesses the function of the arm, shoulder, and hand in patients with disorders or injuries in these areas. Responses are scored on a scale from 0 to 4, where 0 means no difficulty or pain, and 4 indicates severe difficulty or unbearable pain. The total score is calculated by summing responses and normalizing to a 0-100 scale, where 0 indicates no disability (perfect function) and 100 indicates maximum disability or total loss of function.

Time frame
Baseline (before intervention), Immediately post-program (Day 0 after completion)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitat Internacional de Catalunya

Lead sponsor

Consorci Sanitari de Terrassa

Collaborator

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