Effects of MMV Exercise With and Without Verbal Guidance on Shoulder Movement, Fatigue, and Stress in Breast Cancer Survivors

NCT07367334 | Completed DMC

• 1 other identifier: 064/05/2025/ISRB/PGSR/SCPT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks (Base line and 12th Week)

Secondary Outcomes (2)

• FACIT-Fatigue Scale

  12 Weeks (Baseline and 12th week)

• Salivary Cortisol Level

  12 Weeks (Baseline and 12th Week)

Study Arms (2)

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

Interventions

Multimodel Exercises Rehabilitation without Verbal cues OTHER

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.

Multimodel Exercise without Verbal cues

Multimodal Exercise Rehabilitation With Verbal Cueing OTHER

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 Exercise with Verbal cues

Eligibility Criteria

• Age: 35 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saveetha University: lead

Study Sites (1)

Saveetha Medical College and hospital (SMCH)

Chennai, Tamil Nadu, 602105, India

Location

Related Publications (4)

• 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.

  PMID: 40724197 RESULT

• Gupta 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 RESULT

• Zhang 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 RESULT

• Xiong 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 RESULT

Study Officials

• Shenbaga Sundaram Subramanian

  Saveetha College of Physiotherapy, Saveetha Institute of medical and technical sciences (SIMATS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 26, 2026
• Study Start: May 15, 2025
• Primary Completion: August 7, 2025
• Study Completion: September 7, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

IN (1)