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

NCT ID: NCT04166279

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2019-07-19

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.

Detailed Description

Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.

Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.

Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single rehabilitative Treatment

Patients treated within single rehabilitative protocol

Group Type: EXPERIMENTAL

Single rehabilitative treatment

Intervention Type: 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.

Group rehabilitative Treatment

Patients treated within group rehabilitative protocol

Group Type: EXPERIMENTAL

Group rehabilitative treatment

Intervention Type: 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.

Interventions

Single rehabilitative treatment

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.

Intervention Type: OTHER

Group rehabilitative treatment

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Medical Doctor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

URomLS-2019a

Identifier Type: -

Identifier Source: org_study_id