Shoulder DysfunctionNCT03658265

Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy

A study testing 7 days SIE plus 4 weeks PRE, 7 days SIE plus 3 weeks PRE and 3 days SIE plus 4 weeks PRE in people with Shoulder Dysfunction and Breast Cancer, run by Wuhan University at 1 site in China.

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

Who is it for?: Ages 25 to 75 years, women only
Conditions the study is for: Shoulder Dysfunction, Breast Cancer, Modified Radical Mastectomy
What is being tested?: 7 days SIE plus 4 weeks PRE, 7 days SIE plus 3 weeks PRE and 3 days SIE plus 4 weeks PRE
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteChina
Study dates: 10 Sep 2018to 31 May 2020
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 25 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Between the ages of 25 and 75 years;
Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
Postoperative chemotherapy or radiation therapy according to the condition;
No other malignant tumors within 5 years;
No physical therapy related contraindications;
Signing informed consent.

Who cannot join

The result of SLNB is negative who did not receive ALND;
Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
Combined severe heart disease, cerebrovascular disease, and mental illness;
Patients with shoulder joint dysfunction before surgery;
Unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongnan hospital of Wuhan University
Wuhan, Hubei, 430070

Other trials in China

About this study

Official title: Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial

Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.

Conditions: Shoulder Dysfunction, Breast Cancer, Modified Radical Mastectomy
Being tested: 7 days SIE plus 4 weeks PRE, 7 days SIE plus 3 weeks PRE, 3 days SIE plus 4 weeks PRE, 3 days SIE plus 3 weeks PRE
Keywords: breast cancer modified radical mastectomy, shoulder dysfunction, Rehabilitation Training
Medical subject headings: Breast Neoplasms

What participants receive

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

7 days SIE plus 4 weeks PREOther
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
7 days SIE plus 3 weeks PREOther
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
3 days SIE plus 4 weeks PREOther
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
3 days SIE plus 3 weeks PREOther
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

Study groups in NCT03658265
Study group	Role	What they receive
7 days SIE plus 4 weeks PRE	Active comparator	Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery. Receives: Other: 7 days SIE plus 4 weeks PRE
7 days SIE plus 3 weeks PRE	Experimental	Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery. Receives: Other: 7 days SIE plus 3 weeks PRE
3 days SIE plus 4 weeks PRE	Experimental	Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery. Receives: Other: 3 days SIE plus 4 weeks PRE
3 days SIE plus 3 weeks PRE	Experimental	Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery. Receives: Other: 3 days SIE plus 3 weeks PRE

What is being measured

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

Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 1 weeks after surgery
Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 3 weeks after surgery
Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 6 weeks after surgery
Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 9 weeks after surgery
Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 12 weeks after surgery
Constant-Murley Shoulder Score
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Measured: 18 weeks after surgery

Secondary outcomes (5)

Active and passive range of motion
In the standard position, the mobility of the shoulder flexion, extension, external rotation and internal rotation was measured by using protractor. The range of flexion is 0-180°, the range of extension is 0-180°, the range of external rotation is 0-90°, and the range of internal rotation is measured. 0-70°. The assessments will be performed in the active and passive state separately.
Measured: 3 days，1, 2, 3, 6, and 9 weeks after surgery
Shoulder joint muscle strength
In the standard position, the muscle strength of the flexion, extension, external rotation and internal rotation of the shoulder joint were assessed according to the "manual muscle test standard".
Measured: 3 days, 3, 6, 9 weeks after surgery
The power of gripping
In the standard position, the grip of the patient's palm is measured using a dynamometer.
Measured: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
The quality of life assessment of breast cancer patients was evaluated by the total score of the EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life.
Measured: 1, 3, 9, 12, 18 weeks after surgery
SF-36 Health status questionnaire
The quality of life assessment of breast cancer patients was evaluated by the total score of the SF-36 Health status questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life.
Measured: 1, 3, 9, 12, 18 weeks after surgery

Timeline

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

10 Sep 201831 May 2020

First posted5 Sep 2018
Study start10 Sep 2018
Primary completion31 May 2020
Study completion31 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Shoulder DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03658265
Sponsor's protocol ID: CRE2018013
Status last verified: Oct 2020
First submitted: 29 Aug 2018
Last updated: 8 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.

Publications

Shu Q, Yang Y, Shao Y, Teng H, Liao R, Li Z, Wu G, Hou J, Tian J. Comparison of Rehabilitation Training at Different Timepoints to Restore Shoulder Function in Patients With Breast Cancer After Lymph Node Dissection: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):728-737. doi: 10.1016/j.apmr.2023.01.021. Epub 2023 Feb 20.
PubMed 36813015
Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
PubMed 33407753

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shoulder Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03658265
Acronym / sponsor ID: CRE2018013
Conditions: Shoulder Dysfunction, Breast Cancer, Modified Radical Mastectomy
Keywords: breast cancer modified radical mastectomy, shoulder dysfunction, Rehabilitation Training
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Wuhan UniversityUniversity, hospital or other
Study start: 10 Sep 2018 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 5 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
7 days SIE plus 4 weeks PRE	Active comparator	Other: 7 days SIE plus 4 weeks PREParticipants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
7 days SIE plus 3 weeks PRE	Experimental	Other: 7 days SIE plus 3 weeks PREParticipants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
3 days SIE plus 4 weeks PRE	Experimental	Other: 3 days SIE plus 4 weeks PREParticipants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
3 days SIE plus 3 weeks PRE	Experimental	Other: 3 days SIE plus 3 weeks PREParticipants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.

Who may qualify

Ages: 25 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Between the ages of 25 and 75 years;
Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
Postoperative chemotherapy or radiation therapy according to the condition;
No other malignant tumors within 5 years;

Key exclusion criteria (6 listed)

The result of SLNB is negative who did not receive ALND;
Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
Combined severe heart disease, cerebrovascular disease, and mental illness;
Patients with shoulder joint dysfunction before surgery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
7 days SIE plus 4 weeks PREShoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.	Other	7 days SIE plus 4 weeks PRE
7 days SIE plus 3 weeks PREShoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.	Other	7 days SIE plus 3 weeks PRE
3 days SIE plus 4 weeks PREShoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.	Other	3 days SIE plus 4 weeks PRE
3 days SIE plus 3 weeks PREShoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.	Other	3 days SIE plus 3 weeks PRE

Primary outcome

Constant-Murley Shoulder Score
Time frame: 1 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Constant-Murley Shoulder Score
Time frame: 3 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Constant-Murley Shoulder Score
Time frame: 6 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Constant-Murley Shoulder Score
Time frame: 9 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Constant-Murley Shoulder Score
Time frame: 12 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
Constant-Murley Shoulder Score
Time frame: 18 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

5 secondary outcomes

Active and passive range of motion
Time frame: 3 days，1, 2, 3, 6, and 9 weeks after surgery
Shoulder joint muscle strength
Time frame: 3 days, 3, 6, 9 weeks after surgery
The power of gripping
Time frame: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
Time frame: 1, 3, 9, 12, 18 weeks after surgery
SF-36 Health status questionnaire
Time frame: 1, 3, 9, 12, 18 weeks after surgery

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Derived from this study: PubMed 36813015Shu Q, Yang Y, Shao Y, Teng H, Liao R, Li Z, Wu G, Hou J, Tian J. Comparison of Rehabilitation Training at Different Timepoints to Restore Shoulder Function in Patients With Breast Cancer After Lymph Node Dissection: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):728-737. doi: 10.1016/j.apmr.2023.01.021. Epub 2023 Feb 20.
Derived from this study: PubMed 33407753Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.

Related trials for Shoulder Dysfunction

RecruitingPhase 2
Myofascial Dysfunction in Post Stroke Shoulder Pain
Stroke
Enrolling by invitation
Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy
Not yet recruiting
Interscalene Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Shoulder Arthroscopy
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Active, not recruiting
Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
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Not yet recruiting
Ketogenic Diet to Reduce Osteoarthritis Pain in MCI
Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 8 Oct 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 China. 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?

Constant-Murley Shoulder Score (time frame: 1 weeks after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658265, which also lists 2 linked publications.

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 8 Oct 2020.