Breast Cancer SurvivorsNCT07367334
Effects of MMV Exercise With and Without Verbal Guidance on Shoulder Movement, Fatigue, and Stress in Breast Cancer Survivors
A study testing Multimodal Exercise Rehabilitation With Verbal Cueing and Multimodel Exercises Rehabilitation without Verbal cues in people with Breast Cancer Survivors and Range of Motion, run by Saveetha University at 1 site in India.
Trial summary
The goal of this clinical trial is to learn whether a multimodal exercise rehabilitation program with verbal cueing is more effective than the same exercise program without verbal cueing in improving shoulder movement, reducing fatigue, and lowering stress levels in adult female breast cancer survivors undergoing… Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Breast Cancer Survivors, Range of Motion, Cortisol
- What is being tested?
- Multimodal Exercise Rehabilitation With Verbal Cueing and Multimodel Exercises Rehabilitation without Verbal cues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2025to 7 Sep 2025
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: •Female breast cancer survivors (≥3 months, ≤5 years' post-diagnosis)
- Age group: 35-45 years
- FACIT-Fatigue score ≤ 34
- Salivary cortisol levels: 15-30 ng/mL (morning range)
- ROM minimum of 50% of the normal range of motion in the affected shoulder, specifically in the movements of flexion, abduction, and external rotation.
Exclusion Criteria: •Active infection or severe Graft vs Host Disease (GVHD)
- Psychiatric or cognitive impairments
- Severe comorbidities
- Inability to participate in exercise
- Severe fatigue
- Electrolyte imbalance
- Acute organ dysfunction (liver/kidney/lung)
- Active bleeding or recent surgery
- Recent transplantation (e.g., stem cell therapy)
Trial locations and contacts
1 site in 1 country.
India1 site
Saveetha Medical College and hospital (SMCH)
Chennai, Tamil Nadu, 602105
About this study
Official title: Impact of Verbal Cueing in Multimodal Exercise Rehabilitation: A Retrospective Study in Breast Cancer Survivors Undergoing Radiation Therapy
The goal of this clinical trial is to learn whether a multimodal exercise rehabilitation program with verbal cueing is more effective than the same exercise program without verbal cueing in improving shoulder movement, reducing fatigue, and lowering stress levels in adult female breast cancer survivors undergoing radiation therapy.
The main questions it aims to answer are:
Read more
Does a multimodal exercise program with verbal cues improve shoulder range of motion more than the same program without verbal cues? Does verbal cueing during exercise reduce cancer-related fatigue more effectively than exercise without verbal cues? Does verbal cue-based exercise lead to greater improvement in salivary cortisol levels compared to exercise without verbal cues?
Researchers will compare multimodal exercise with verbal cues to multimodal exercise without verbal cues to see if verbal guidance improves physical function, fatigue, and stress regulation.
Participants will be adult female breast cancer survivors undergoing radiation therapy who are enrolled in this clinical trial. Eligible participants will be assigned to one of two groups and will take part in a supervised multimodal exercise rehabilitation program for a duration of 12 weeks. Depending on group allocation, participants will perform the same set of exercises either with structured verbal cues provided by the therapist or without verbal cues. Throughout the study period, participants will attend regular exercise sessions and follow the prescribed exercise protocol. Shoulder range of motion will be assessed using standard goniometric measurements, cancer-related fatigue will be evaluated using the FACIT-Fatigue questionnaire, and physiological stress will be measured through salivary cortisol levels. All assessments will be conducted before the start of the exercise program and again at the end of the 12-week intervention period.
Read the detailed description
Breast cancer survivors undergoing radiation therapy frequently experience shoulder dysfunction, cancer-related fatigue, and increased physiological stress, which adversely affect functional ability and quality of life. Exercise-based rehabilitation is known to improve physical and psychological outcomes in this population; however, the added value of verbal cueing during exercise has not been clearly established.
This clinical trial evaluates the effectiveness of a multimodal exercise rehabilitation program delivered with verbal cues compared to the same program delivered without verbal cues. The multimodal exercise program includes aerobic training, resistance exercises, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing fatigue, and regulating stress responses. Verbal cueing involves therapist-provided instructions, feedback, and encouragement intended to enhance motor learning, exercise execution, and participant engagement.
Participants are assigned to one of two groups and complete a supervised 12-week exercise program. Both groups follow identical exercise protocols in terms of frequency, duration, and intensity, differing only in the presence or absence of verbal guidance. Outcomes are assessed at baseline and post-intervention. Shoulder range of motion is measured using goniometry, fatigue is evaluated using the FACIT-Fatigue scale, and physiological stress is assessed through salivary cortisol levels.
This study aims to determine whether verbal cueing enhances the effectiveness of multimodal exercise rehabilitation and to support evidence-based physiotherapy strategies for improving functional recovery and well-being in breast cancer survivors undergoing radiation therapy.
- Conditions
- Breast Cancer Survivors, Range of Motion, Cortisol, Shoulder Dysfunction, Fatigue After Adjuvant Breast Cancer Treatment
- Being tested
- Multimodal Exercise Rehabilitation With Verbal Cueing, Multimodel Exercises Rehabilitation without Verbal cues
- Keywords
- Good Health and Well-Being, Quality Education, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise Rehabilitation With Verbal CueingOther
The intervention consisted supervised multimodal exercise rehabilitation program designed for breast cancer survivors undergoing radiation therapy. Each exercise session lasted approximately 45 minutes and includes aerobic exercises, resistance training, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing cancer-related fatigue, and regulating physiological stress. The program is delivered three times per week for 12 weeks, with exercise intensity and progression tailored to individual tolerance and safety. In one arm, exercises are delivered with structured verbal cueing provided by the therapist, including instructions, corrective feedback, breathing guidance, pacing, and motivational support throughout the session. In the comparison arm, the same exercises are performed without verbal cueing after an initial demonstration.
Multimodel Exercises Rehabilitation without Verbal cuesOther
Participants in this arm received a supervised multimodal exercise rehabilitation program conducted without verbal cueing. Each exercise session lasted approximately 45 minutes and is performed three times per week for 12 weeks. The program includes aerobic exercises, resistance training, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing cancer-related fatigue, and regulating physiological stress.
Participants performed the exercises following an initial demonstration, without ongoing verbal instructions, feedback, or encouragement during exercise execution. Exercise frequency, duration, intensity, and progression are standardized and identical to the verbal cueing group, ensuring consistency across interventions. The absence of verbal cueing allows evaluation of the effects of exercise delivery without therapist-guided verbal input.
| Study group | Role | What they receive |
|---|---|---|
| Multimodel Exercise with Verbal cues | Experimental | Not described Receives: Other: Multimodal Exercise Rehabilitation With Verbal Cueing |
| Multimodel Exercise without Verbal cues | Active comparator | Not described Receives: Other: Multimodel Exercises Rehabilitation without Verbal cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of motion
Shoulder range of motion was assessed as a primary functional outcome, focusing on shoulder flexion, abduction, and external rotation of the affected upper limb. Active ROM was measured using a standard universal goniometer following standardized anatomical landmarks and testing positions. Assessments were performed at baseline and after completion of the intervention period. Improvements in shoulder ROM indicate enhanced joint mobility, soft tissue flexibility, and functional use of the upper limb. Goniometric measurement is a reliable and widely accepted method for evaluating shoulder function in oncological rehabilitation.
Measured: 12 weeks (Base line and 12th Week)
Secondary outcomes (2)
FACIT-Fatigue Scale
Cancer-related fatigue was evaluated using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale, a validated, self-administered questionnaire designed specifically to assess fatigue and its impact on daily functioning in individuals with chronic illness, including cancer. The FACIT-F consists of 13 items rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"), with total scores ranging from 0 to 52. Higher scores indicate lower levels of fatigue and better functional well-being. Participants completed the questionnaire at baseline and following the completion of the intervention period. Fatigue is one of the most prevalent and persistent symptoms experienced by breast cancer survivors undergoing radiation therapy and can significantly impair physical performance, emotional health, and quality of life. The FACIT-F Scale has demonstrated excellent reliability, validity, and sensitivity to change in oncology population
Measured: 12 Weeks (Baseline and 12th week)
Salivary Cortisol Level
Physiological stress response was assessed through the measurement of salivary cortisol levels, a non-invasive biomarker reflecting hypothalamic pituitary adrenal (HPA) axis activity. Saliva samples were collected under standardized conditions to minimize the influence of diurnal variation in cortisol secretion. Samples were obtained at consistent times of the day both before and after the intervention period. Elevated cortisol levels are commonly associated with chronic stress, fatigue, and disrupted neuroendocrine regulation in breast cancer survivors undergoing active treatment. A reduction or normalization of salivary cortisol levels following the intervention indicates improved stress regulation, enhanced autonomic balance, and better physiological adaptation to treatment-related stress.
Measured: 12 Weeks (Baseline and 12th Week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 May 2025
- Primary completion7 Aug 2025
- Study completion7 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamil Ponni Sivamani, Saveetha University
- Investigators
- Shenbaga Sundaram Subramanian, Principal investigator, Saveetha College of Physiotherapy, Saveetha Institute of medical and technical sciences (SIMATS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367334
- Sponsor's protocol ID
- 064/05/2025/ISRB/PGSR/SCPT
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guardamagna L, Diamanti O, Artioli G, Casole L, Bernardi M, Bonadies F, Zennaro E, Modena GM, Nania T, Dellafiore F. Breast Cancer Survivors' Perception on Health Promotion and Healthy Lifestyle: A Systematic Review and Qualitative Meta-Synthesis. Int J Environ Res Public Health. 2025 Jul 17;22(7):1131. doi: 10.3390/ijerph22071131.
PubMed 40724197Gupta B, Gupta K, Narula K, Sharma P, Mittal A. The Effect of Exercise on Quality of Life among Patients and Survivors of Breast Cancer: A Systematic Review and Meta-Analysis. Asian Pac J Cancer Prev. 2025 Mar 1;26(3):715-723. doi: 10.31557/APJCP.2025.26.3.715.
PubMed 40156386Zhang Y, Ji Y, Liu S, Li J, Wu J, Jin Q, Liu X, Duan H, Feng Z, Liu Y, Zhang Y, Lyu Z, Song F, Song F, Yang L, Liu H, Huang Y. Global burden of female breast cancer: new estimates in 2022, temporal trend and future projections up to 2050 based on the latest release from GLOBOCAN. J Natl Cancer Cent. 2025 Feb 13;5(3):287-296. doi: 10.1016/j.jncc.2025.02.002. eCollection 2025 Jun.
PubMed 40693239Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4.
PubMed 39966355
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Verbal Cueing in Multimodal Exercise Rehabilitation: A Retrospective Study in Breast Cancer Survivors Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT07367334
- Acronym / sponsor ID
- 064/05/2025/ISRB/PGSR/SCPT
- Conditions
- Breast Cancer Survivors, Range of Motion, Cortisol, Shoulder Dysfunction, Fatigue After Adjuvant Breast Cancer Treatment
- Keywords
- Good Health and Well-Being, Quality Education, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 26 Jan 2026 (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.
The goal of this clinical trial is to learn whether a multimodal exercise rehabilitation program with verbal cueing is more effective than the same exercise program without verbal cueing in improving shoulder movement, reducing fatigue, and lowering stress levels in adult female breast cancer survivors undergoing radiation therapy.
The main questions it aims to answer are:
Does a multimodal exercise program with verbal cues improve shoulder range of motion more than the same program without verbal cues? Does verbal cueing during exercise reduce cancer-related fatigue more effectively than exercise without verbal cues? Does verbal cue-based exercise lead to greater improvement in salivary cortisol levels compared to exercise without verbal cues?
Researchers will compare multimodal exercise with verbal cues to multimodal exercise without verbal cues to see if verbal guidance improves physical function, fatigue, and stress regulation.
Participants will be adult female breast cancer survivors undergoing radiation therapy who are enrolled in this clinical trial. Eligible participants will be assigned to one of two groups and will take part in a supervised multimodal exercise rehabilitation program for a duration of 12 weeks. Depending on group allocation, participants will perform the same set of exercises either with structured verbal cues provided by the therapist or without verbal cues. Throughout the study period, participants will attend regular exercise sessions and follow the prescribed exercise protocol. Shoulder range of motion will be assessed using standard goniometric measurements, cancer-related fatigue will be evaluated using the FACIT-Fatigue questionnaire, and physiological stress will be measured through salivary cortisol levels. All assessments will be conducted before the start of the exercise program and again at the end of the 12-week intervention period.
Detailed description
Breast cancer survivors undergoing radiation therapy frequently experience shoulder dysfunction, cancer-related fatigue, and increased physiological stress, which adversely affect functional ability and quality of life. Exercise-based rehabilitation is known to improve physical and psychological outcomes in this population; however, the added value of verbal cueing during exercise has not been clearly established.
This clinical trial evaluates the effectiveness of a multimodal exercise rehabilitation program delivered with verbal cues compared to the same program delivered without verbal cues. The multimodal exercise program includes aerobic training, resistance exercises, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing fatigue, and regulating stress responses. Verbal cueing involves therapist-provided instructions, feedback, and encouragement intended to enhance motor learning, exercise execution, and participant engagement.
Participants are assigned to one of two groups and complete a supervised 12-week exercise program. Both groups follow identical exercise protocols in terms of frequency, duration, and intensity, differing only in the presence or absence of verbal guidance. Outcomes are assessed at baseline and post-intervention. Shoulder range of motion is measured using goniometry, fatigue is evaluated using the FACIT-Fatigue scale, and physiological stress is assessed through salivary cortisol levels.
This study aims to determine whether verbal cueing enhances the effectiveness of multimodal exercise rehabilitation and to support evidence-based physiotherapy strategies for improving functional recovery and well-being in breast cancer survivors undergoing radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodel Exercise with Verbal cues | Experimental | Other: Multimodal Exercise Rehabilitation With Verbal Cueing |
| Multimodel Exercise without Verbal cues | Active comparator | Other: Multimodel Exercises Rehabilitation without Verbal cues |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Multimodal Exercise Rehabilitation With Verbal CueingThe intervention consisted supervised multimodal exercise rehabilitation program designed for breast cancer survivors undergoing radiation therapy. Each exercise session lasted approximately 45 minutes and includes aerobic exercises, resistance training, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing cancer-related fatigue, and regulating physiological stress. The program is delivered three times per week for 12 weeks, with exercise intensity and progression tailored to individual tolerance and safety. In one arm, exercises are delivered with structured verbal cueing provided by the therapist, including instructions, corrective feedback, breathing guidance, pacing, and motivational support throughout the session. In the comparison arm, the same exercises are performed without verbal cueing after an initial demonstration. | Other | Multimodel Exercise with Verbal cues |
| Multimodel Exercises Rehabilitation without Verbal cuesParticipants in this arm received a supervised multimodal exercise rehabilitation program conducted without verbal cueing. Each exercise session lasted approximately 45 minutes and is performed three times per week for 12 weeks. The program includes aerobic exercises, resistance training, flexibility exercises, and relaxation techniques aimed at improving shoulder mobility, reducing cancer-related fatigue, and regulating physiological stress. Participants performed the exercises following an initial demonstration, without ongoing verbal instructions, feedback, or encouragement during exercise execution. Exercise frequency, duration, intensity, and progression are standardized and identical to the verbal cueing group, ensuring consistency across interventions. The absence of verbal cueing allows evaluation of the effects of exercise delivery without therapist-guided verbal input. | Other | Multimodel Exercise without Verbal cues |
Primary outcome
Shoulder Range of motion
Time frame: 12 weeks (Base line and 12th Week)
Shoulder range of motion was assessed as a primary functional outcome, focusing on shoulder flexion, abduction, and external rotation of the affected upper limb. Active ROM was measured using a standard universal goniometer following standardized anatomical landmarks and testing positions. Assessments were performed at baseline and after completion of the intervention period. Improvements in shoulder ROM indicate enhanced joint mobility, soft tissue flexibility, and functional use of the upper limb. Goniometric measurement is a reliable and widely accepted method for evaluating shoulder function in oncological rehabilitation.
2 secondary outcomes
FACIT-Fatigue Scale
Time frame: 12 Weeks (Baseline and 12th week)
Salivary Cortisol Level
Time frame: 12 Weeks (Baseline and 12th Week)
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 27 Jan 2026.
- Results publication: PubMed 40724197Guardamagna L, Diamanti O, Artioli G, Casole L, Bernardi M, Bonadies F, Zennaro E, Modena GM, Nania T, Dellafiore F. Breast Cancer Survivors' Perception on Health Promotion and Healthy Lifestyle: A Systematic Review and Qualitative Meta-Synthesis. Int J Environ Res Public Health. 2025 Jul 17;22(7):1131. doi: 10.3390/ijerph22071131.
- Results publication: PubMed 40156386Gupta B, Gupta K, Narula K, Sharma P, Mittal A. The Effect of Exercise on Quality of Life among Patients and Survivors of Breast Cancer: A Systematic Review and Meta-Analysis. Asian Pac J Cancer Prev. 2025 Mar 1;26(3):715-723. doi: 10.31557/APJCP.2025.26.3.715.
- Results publication: PubMed 40693239Zhang Y, Ji Y, Liu S, Li J, Wu J, Jin Q, Liu X, Duan H, Feng Z, Liu Y, Zhang Y, Lyu Z, Song F, Song F, Yang L, Liu H, Huang Y. Global burden of female breast cancer: new estimates in 2022, temporal trend and future projections up to 2050 based on the latest release from GLOBOCAN. J Natl Cancer Cent. 2025 Feb 13;5(3):287-296. doi: 10.1016/j.jncc.2025.02.002. eCollection 2025 Jun.
- Results publication: PubMed 39966355Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4.
- Individual participant dataSharing planned: Undecided
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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.
Shenbaga Sundaram Subramanian principal investigator
Saveetha College of Physiotherapy, Saveetha Institute of medical and technical sciences (SIMATS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise Rehabilitation With Verbal Cueing and Multimodel Exercises Rehabilitation without Verbal cues in people with Breast Cancer Survivors and Range of Motion, run by Saveetha University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Jan 2026. 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 India. 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 Range of motion (time frame: 12 weeks (Base line and 12th Week)). 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 NCT07367334, which also lists 4 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 27 Jan 2026.