Inertial Rehabilitation in Women After Mastectomy

NCT04621942 | Completed

• 1 other identifier: University in Zielona Gora
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Mastectomy; Lymphedema

Keywords

mastectomy; inertial rehabilitation; BCRL

Outcome Measures

Primary Outcomes (1)

• Shoulder muscle strength

  Strength of shoulder flexors and extensors and strength of shoulder abductors and adductors were tested in the standing position using Cyklotren inertial device. After warm-up, each participant performed a 10-second maximal test of the right and left arm separately, with a 2-minute break between measurements. For all measurement 5 kg load was applied. The range of motion was approximately 90 degree (where 0 degrees corresponded to the arm along the trunk). Data collection was preceded by a familiarization session.

  6 weeks

Secondary Outcomes (2)

• Breast cancer-related lymphedema (BCRL)

  6 weeks

• Disabilities of the arm, shoulder and hand test (DASH)

  6 weeks

Study Arms (2)

Training group

EXPERIMENTAL

12 women after mastectomy. 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). Moreover, women from training group participated in rehabilitation gymnastics twice a week.

Other: inertial rehabilitation; Other: gymnastic rehabilitation

Control group

ACTIVE COMPARATOR

12 women after mastectomy. All women participated in rehabilitation gymnastics twice a week.

Other: gymnastic rehabilitation

Interventions

inertial rehabilitation OTHER

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.

Training group

gymnastic rehabilitation OTHER

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.

Control group; Training group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mastectomy performed at least 6 months before the study
• lack of fractures in the prior 3 months
• lack of tendon and ligament injuries in the prior 2 months

You may not qualify if:

• mastectomy was performed less than 6 months before the study
• fractures in the prior 3 months
• tendon and ligament injuries in the last 2 months
• serious heart disease
• cerebral palsy
• limb amputations

Sponsors & Collaborators

• University in Zielona Góra: lead

Study Sites (1)

University in Zielona Góra

Zielona Góra, 65-417, Poland

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Institute of Health Sciences

Model Details: the study finally included 24 women after mastectomy (age, 66.2 ± 10.6 years, range 43-82 years; body mass, 72.7 ± 10.6 kg; height, 159 ± 5.2 cm), 17 after simple mastectomy and 7 after breast conserving therapy. The participants were randomly allocated into two groups: a training group (T; n = 12) and a control group (C; n = 12) using chit method. The T group participated in 6 weeks of inertial training while the control group maintain their normal daily activity. All women still participated in rehabilitation gymnastics twice a week.

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 9, 2020
• Study Start: April 2, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 24, 2019
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)