The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison

NCT04166279 | Completed

• 1 other identifier: URomLS-2019a
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.

Conditions

Breast Cancer; Breast Cancer Lymphedema; Pain; Pain, Postoperative; Pain, Chronic; Mastectomy; Lymphedema; Breast Surgery

Keywords

Breast Cancer; Pain Chronic and Postoperative; Lymphedema; Posture; Target - Reaching movement; Breast surgery; Functional impotence; Rehabilitive treatment; Physiotherapy; Scapula tilting

Outcome Measures

Primary Outcomes (1)

• Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement

  The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement.

  T0 baseline - T1 (6 weeks) - T2 (3 months)

Secondary Outcomes (6)

• Change [over time] of Visual Analogue Scale (VAS)

  T0 baseline - T1 (6 weeks) - T2 (3 months)

• Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

  T0 baseline - T1 (6 weeks) - T2 (3 months)

• Change [over time] of Movement Duration (MD) of biomechanical reaching movement

  T0 baseline - T1 (6 weeks) - T2 (3 months)

• Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement

  T0 baseline - T1 (6 weeks) - T2 (3 months)

• Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement

  T0 baseline - T1 (6 weeks) - T2 (3 months)

Other Outcomes (1)

• Change [over time] of range of Motion (ROM) of shoulder

  T0 baseline - T1 (6 weeks) - T2 (3 months)

Study Arms (2)

Single rehabilitative Treatment

EXPERIMENTAL

Patients treated within single rehabilitative protocol

Other: Single rehabilitative treatment

Group rehabilitative Treatment

EXPERIMENTAL

Patients treated within group rehabilitative protocol

Other: Group rehabilitative treatment

Interventions

Single rehabilitative treatment OTHER

The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week).). The protocol included a first phase consist in low impact aerobics warming (15-20 minutes), then diaphragmatic breathing and postural exercises for the midline alignment. The awareness of abdominal breathing represents the preliminary phase for a complete psychophysical relaxation of the patient, an important prerequisite for the correct execution of subsequent mobility, stretching and strengthening exercises of spine, scapula and upper limb. Subsequently, isometric strengthening exercises for shoulder stabilizing muscles, first passively and, subsequently, with supervision, were performed. Specific exercises, for passive mobilization and stabilization of the scapula, cervical pumping and stretching of the pectoral muscles, have been performed.

Single rehabilitative Treatment

Group rehabilitative treatment OTHER

Four-five patients for group. The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week). The protocol included at first week mainly breathing techniques, then we introduced exercises gradually more active, according to the improvements of the execution. The exercises had the aim to improve the opening of the scapular chain and to increase the amplitude of the range of motion in order to stimulate better neuromuscular control during the movement of scapular retropulsion, to stretch the pectoral muscles following the rhythm of the breath and the tissues affected by post-surgical scars and fibrotic effects, finally to reinforcing, against gravity, the musculature of the shoulders and back.

Group rehabilitative Treatment

Eligibility Criteria

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

You may qualify if:

• total mastectomy carried out 12 months prior to recruitment for rehabilitation with breast prostheses or tissue expanders performed
• age from 18 to 60 years
• body mass index (BMI) \< 30
• no cognitive dysfunctions ( Mini Mental State Examination MMSE \> 24)

You may not qualify if:

• presence of lymphangitis or mastitis
• presence of metastasis
• surgical complications
• neurological deficits
• shoulder joint problems before surgery
• severe-moderate lymphedema and web axillary syndrome
• visual problem not corrected by lenses

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema; Pain; Pain, Postoperative; Chronic Pain; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: January 8, 2018
• Primary Completion: April 15, 2019
• Study Completion: July 19, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

IT (1)