Clinical trial · Interventional
Effects of MMV Exercise With and Without Verbal Guidance on Shoulder Movement, Fatigue, and Stress in Breast Cancer Survivors
Impact of Verbal Cueing in Multimodal Exercise Rehabilitation: A Retrospective Study in Breast Cancer Survivors Undergoing Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Cortisol | — | UNRESOLVED | — |
| Fatigue After Adjuvant Breast Cancer Treatment | — | UNRESOLVED | — |
| Range of Motion | — | UNRESOLVED | — |
| Shoulder Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Exercise Rehabilitation With Verbal Cueing | Other | — | UNRESOLVED |
| Multimodel Exercises Rehabilitation without Verbal cues | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodel Exercise with Verbal cues
- interventionNames
- Other: Multimodal Exercise Rehabilitation With Verbal Cueing
- type
- ACTIVE_COMPARATOR
- label
- Multimodel Exercise without Verbal cues
- interventionNames
- Other: Multimodel Exercises Rehabilitation without Verbal cues
Primary outcomes (1)
- measure
- Shoulder Range of motion
- timeFrame
- 12 weeks (Base line and 12th Week)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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)
References
Publications (4)
- RESULTGuardamagna 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. PMID 40724197
- RESULTGupta 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. PMID 40156386
- RESULTZhang 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. PMID 40693239
- RESULTXiong 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. PMID 39966355