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

S

Saveetha University

Status

Completed

Conditions

Fatigue After Adjuvant Breast Cancer Treatment
Shoulder Dysfunction
Breast Cancer Survivors
Range of Motion
Cortisol

Treatments

Other: Multimodal Exercise Rehabilitation With Verbal Cueing
Other: Multimodel Exercises Rehabilitation without Verbal cues

Study type

Interventional

Funder types

Other

Identifiers

NCT07367334
064/05/2025/ISRB/PGSR/SCPT

Details and patient eligibility

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.

Full 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.

Enrollment

34 patients

Sex

Female

Ages

35 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Multimodel Exercise with Verbal cues
Experimental group
Treatment:
Other: Multimodal Exercise Rehabilitation With Verbal Cueing
Multimodel Exercise without Verbal cues
Active Comparator group
Treatment:
Other: Multimodel Exercises Rehabilitation without Verbal cues

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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