CompletedNot Applicable

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

India34 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range35 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Shoulder Range of motion

Timeframe: 12 weeks (Base line and 12th Week)

Trial details

NCT IDNCT07367334

SponsorSaveetha University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-07