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Breast CancerNCT04621942

Inertial Rehabilitation in Women After Mastectomy

A study testing inertial rehabilitation and gymnastic rehabilitation in people with Breast Cancer and Mastectomy; Lymphedema, run by University in Zielona Góra at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Mastectomy; Lymphedema
What is being tested?
inertial rehabilitation and gymnastic rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 sitePoland
Study dates
2 Apr 2019to 24 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • University in Zielona Góra

    Zielona Góra, 65-417

Other trials in Poland

About this study

Official title: Is Inertial Training Effective and Safe Rehabilitation Method in Women After Mastectomy?

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.

Read the detailed description

A group of 30 women who underwent mastectomy procedure attended an initial meeting and all of them agreed to participate in the study. The participants were members of an association of people after mastectomy (Amazons Association) and regularly participated in rehabilitation gymnastics twice a week for at least 3 years. All women met the including criteria: mastectomy was performed at least 6 months before the study, lack of: fractures in the prior 3 months, tendon and ligament injuries in the prior 2 months, serious heart disease, cerebral palsy, and limb amputations. All subjects received permission from their physician to participate in the experiment. Therefore, 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. All participants gave written informed consent to take part in the study.

Testing

Before and after training participants were evaluated using the following tests:

  • strength of shoulder muscles measurements
  • body composition measurements
  • breast cancer-related lymphedema (BCRL) evaluation
  • disabilities of the arm, shoulder and hand test (DASH)

Strength of shoulder muscles measurement. Strength of shoulder flexors and extensors and strength of shoulder abductors and adductors were tested in the standing position using Cyklotren inertial device (Naczk 2015). 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. Participants position during strength testing and inertial training is showed on Figure1. For all measurement 5 kg load was applied. It should be noted here that the same load during inertial training doesn't mean the working muscles develop the same force. During inertial exercise force developed by muscle strongly depend on movement velocity, greater movement velocity results greater muscle load and greater force is developed (the force value is presented on-line on the Cyklotren's screen). 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.

Body composition measurements Bioelectric impedance were used to evaluate the body composition of participants (Tanita 980 MC, Japan). The participants were asked to maintain a normal state of hydration, and they were not allowed to exercise, eat, or drink alcohol or caffeine for 12 h preceding the measurements. Measurements were conducted in the morning according to the manufacturer's guidelines. Fat mass, muscle mass, amount of water were used in future analyses.

Breast cancer-related lymphedema evaluation To evaluate the influence of inertial rehabilitation on breast cancer-related lymphedema bioimpedance spectroscopy was used. This technique allows to detect small changes in extracellular fluid (ECF) and subclinical BCRL, therefore allows for the subclinical detection of BCRL when visible swelling is not apparent. Measurements were done using L-Dex U400 unit (ImpediMed Limited, Australia). The feasibility and clinical utility of implementing L-Dex measurements in routine breast cancer care was confirmed in previous studies (Laidley and Anglin 2016, Kilgore et al 2018). During the measurements patients were lying supine on a non-metallic surface a standardized technique according to Laidley and Anglin (2016) methodology.

Disabilities of the arm, shoulder and hand test (DASH) To evaluate ability of the participants do the different daily activities DASH questionnaire was completed. DASH questionnaire is a standardized measure which captures the patients' own perspective of their upper extremity health status (Jester et. al 2005). During the questionnaire completing subjects were provided with conditions that allowed them to mark the answers freely.

Workout 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.

Statistical analysis Normality of distribution of the data was tested using the Shapiro-Wilk method. Descriptive statistics, including means and standard deviations, were calculated. For testing significance of changes analysis of variance (ANOVA) were used. The simple effect of training for each participant was defined as a relative increase in an analyzed variable after training compared with the before-training value.Lower and upper borders of 95% confidence intervals for relative increase were calculated.

Differences in relative increases between groups were tested with one-way ANOVA. If differences were detected, the Scheffé post hoc procedure was used to determine where the differences occurred. The level of significance was set at P ≤ 0.05. The effect size (ES) of the training was calculated using the paired two-sample t-test, and according to Goulet-Pelletiera and Cousineaua (2018) Cohen's d with Hedges g correction was determined. The scale presented by Cohen indicates that d < 0.41 represents a small ES, 0.41-0.70 a moderate ES, and higher than 0.70 a large ES.

Being tested
inertial rehabilitation, gymnastic rehabilitation
Keywords
mastectomy, inertial rehabilitation, BCRL
Medical subject headings
Breast Neoplasms, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inertial rehabilitationOther

    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.

  • gymnastic rehabilitationOther

    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.

Study groups in NCT04621942
Study groupRoleWhat they receive
Training groupExperimental12 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.
Receives: Other: inertial rehabilitation; Other: gymnastic rehabilitation
Control groupActive comparator12 women after mastectomy. All women participated in rehabilitation gymnastics twice a week.
Receives: Other: gymnastic rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. Breast cancer-related lymphedema (BCRL)

    To evaluate the influence of inertial rehabilitation on breast cancer-related lymphedema bioimpedance spectroscopy was used. This technique allows to detect small changes in extracellular fluid (ECF) and subclinical BCRL, therefore allows for the subclinical detection of BCRL when visible swelling is not apparent. Measurements were done using L-Dex U400 unit (ImpediMed Limited, Australia). The feasibility and clinical utility of implementing L-Dex measurements in routine breast cancer care was confirmed in previous studies (Laidley and Anglin 2016, Kilgore et al 2018). During the measurements patients were lying supine on a non-metallic surface a standardized technique.

    Measured: 6 weeks

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

    To evaluate ability of the participants do the different daily activities DASH questionnaire was completed. DASH questionnaire is a standardized measure which captures the patients' own perspective of their upper extremity health status (Jester et. al 2005). During the questionnaire completing subjects were provided with conditions that allowed them to mark the answers freely. The DASH test is used to assess the quality of life in women after mastectomy.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start2 Apr 2019
  3. Primary completion30 Jun 2019
  4. Study completion24 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621942
Sponsor's protocol ID
University in Zielona Gora
Status last verified
Nov 2020
First submitted
30 Oct 2020
Last updated
9 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing inertial rehabilitation and gymnastic rehabilitation in people with Breast Cancer and Mastectomy; Lymphedema, run by University in Zielona Góra at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder muscle strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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