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Starting soon Not applicable

Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

NCT06234150 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-04-01
Last updated
2024-02-20

Condition(s) studied

Breast NeoplasmsExercise TherapyChemotherapy-Related Cognitive ImpairmentCognitive DysfunctionDance Therapy

Investigational drug(s) / intervention(s)

Aerobic danceFast-walking

Aerobic dance: Patients assigned to the aerobic dance group will participate in a one-on-one training session before their first chemotherapy session, including aerobic dance instruction, teleconference participation, use of a heart rate bracelet, and use of the Perceived Exertion Rating (PRE) until they master all components. The researchers will also provide participants with instructional videos to view anytime. We will require an exercise log to record the number of workouts, the intensity of the workout using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Fast-walking: Patients assigned to the fast-walking group will participate in a one-on-one training session before their first chemotherapy session, including fast-walking instruction, teleconference participation, use of a heart rate bracelet, and use of the Perceived Exertion Rating (PRE) until they master all components. The researchers will also provide participants with instructional videos to view anytime. We will require an exercise log to record the number of workouts, the intensity of the workout using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Study summary

The goal of this clinical trial is to learn about breast cancer patients. The main questions it aims to answer are:

* Does Aerobic Dance During Chemotherapy Improve Cognitive Function in Breast Cancer Patients?
* Does the efficacy of aerobic dance differ from fast walking of equal intensity? Recruited patients will be randomly assigned to three groups: (1) aerobic dance group, (2) fast walking group, and (3) usual care group.

The aerobic dance and fast-walking groups participated in supervised exercise lasting 50 minutes thrice a week for 12 weeks.

The goal of this study's findings is to develop practical strategies for managing breast cancer-related cognitive impairment.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 18-65 years old * Newly diagnosed, histologically confirmed, resected stage I-IIIa BC * Scheduled for chemotherapy with Epirubicin+ Cyclophosphamide (EC) regimen * Presence of objective cognitive decline Exclusion Criteria: * Regular exercise habits (exercise at moderate intensity for 30 minutes a day, 3 days a week, for at least 3 months.), * Motor dysfunction * Alzheimer's disease * Vascular dementia

Primary outcome measure(s)

  • Shape Trail Test (STT) — From enrollment to the end of treatment at 12 weeks
    Chinese version of the Shape Test (STT-A, STT-B). This test is widely used in China to assess a person's executive function. The Tracking Test (TMT) was created by Partington in 1938. It is divided into two parts, A and B. In part A, the subject must connect 25 numbers on a piece of paper in a specific order; in part B, the subject must connect 25 numbers and letters in alternating order. Since some Chinese may not be familiar with the English alphabet, we used the Chinese version of round and square numbers. The numbers should be connected in sequence, alternating between different shapes. This helps to test the subject's ability to transfer stereotypes, hand-eye coordination, spatial perception and memory. The faster the response, the higher the sensitivity.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06234150 on ClinicalTrials.gov ↗ ← All trials in China