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

Sponsored by Saveetha University

About this trial

Last updated 4 months ago

Study ID

064/05/2025/ISRB/PGSR/SCPT

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

35 to 45 Years
Female

Trial Timing

Ended 9 months ago

What is this trial about?

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.

What are the Participation Requirements?

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)