MedTrace Logo

Inertial Rehabilitation in Women After Mastectomy

NCT04621942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-09

No results posted yet for this study

Summary

The aim of the study was to evaluate the impact of inertial rehabilitation on: shoulder flexors, extensors and shoulder abductors and adductors strength, breast cancer-related lymphedema (BCRL) and quality of life in women after mastectomy. Twenty-four women after mastectomy were randomized to a training (T; n = 12) or control group (C; n = 12). The T group performed inertial training twice a week for 6 weeks using a Cyklotren inertial device. Each training session included warm-up and 4 sets of shoulder flexors, extensors, abductors, and adductors, with the right and left arms worked. The training loads for all exercises was equal 5 kg. Before and after training the maximum force of trained muscles was tested under training conditions. Body composition, BCRL, disabilities of the arm, shoulder and hand (DASH) were also evaluated. Inertial rehabilitation caused significant improvement in strength in all tested muscles in T whereas changes in C were insignificant. Quality of life evaluated by DASH score decreased significantly in T and and did not change in C. Moreover, BCRL and body composition did not change significantly following intervention in both groups. Inertial exercises can be useful rehabilitation method in women treated for breast cancer.

Conditions

Interventions

OTHER

inertial rehabilitation

Inertial rehabilitation was performed twice a week (Monday and Thursday, between 5:00 and 8:00 PM) for 6 weeks using Cyklotren device (Inerion, Poland). Exercises were conducted by the same 2 researchers. Each training session included warm-up and 4 sets of shoulder flexors, extensors, abductors, and adductors, with the right and left arms worked separately (16 sets for left and 16 sets for right arm). Each set lasted 15 seconds, a 2-minute break occurred between consecutive sets (without rest period between right and left arm). For all trained muscles 5 kg load was applied. During the training participants developed 70% of their maximal force achieved during the strength measurement. Participants observed developed during training force value displayed on-line on the screen. Cyklotren software allows to set the upper and lower limit of force; when developed strength was to low or to high a beep signal was emitted to correct participant force.

OTHER

gymnastic rehabilitation

All women (from T and C group) participated in rehabilitation gymnastics twice a week during experiment (6 weeks). The gymnastics was conducted by a physiotherapist specializing in rehabilitation of women after mastectomy. The trehabilitation session lasted 45 minutes. During the sessions, the women mainly performed exercises involved shoulders, chest and the upper limbs muscles. Moreover, abdomen and back muscles were exercised.

Sponsors & Collaborators

  • University in Zielona Góra

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-06-30
Completion
2019-07-24

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621942 on ClinicalTrials.gov