Impact of Verbal Cueing in Multimodal Exercise Rehabilitation: A Retrospective Study in Breast Cancer Survivors Undergoing Radiation Therapy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Saveetha University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Shoulder Range of motion
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 35 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Multimodel Exercise with Verbal cues
Intervention: Multimodal Exercise Rehabilitation With Verbal Cueing (Other)
Multimodel Exercise without Verbal cues
Intervention: Multimodel Exercises Rehabilitation without Verbal cues (Other)
Outcomes
Primary Outcomes
Shoulder Range of motion
Time Frame: 12 weeks (Base line and 12th Week)
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.
Secondary Outcomes
- FACIT-Fatigue Scale(12 Weeks (Baseline and 12th week))
- Salivary Cortisol Level(12 Weeks (Baseline and 12th Week))
Investigators
Tamil Ponni Sivamani
Principal Investigator
Saveetha University