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

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

Interventions

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.

Sponsors & Collaborators

• Saveetha University

  lead OTHER

Principal Investigators

• Shenbaga Sundaram Subramanian · Saveetha College of Physiotherapy, Saveetha Institute of medical and technical sciences (SIMATS)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-15

Primary Completion

2025-08-07

Completion

2025-09-07

Countries

• India

Study Locations