NCT07367334

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Saveetha University · Academic / Other
• Sex: Female
• Age: 35 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Multimodal Exercise Rehabilitation With Verbal Cueing	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.
OTHER	Multimodel Exercises Rehabilitation without Verbal cues	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.

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-08-07
• Completion: 2025-09-07
• First posted: 2026-01-26
• Last updated: 2026-01-27

Locations

1 site across 1 country: India