Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic dance

    Other intervention

    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

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Aerobic danceExperimental treatment 1 intervention
Group B: Fast-walkingExperimental treatment 1 intervention
Group C: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Shape Trail Test (STT)

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

the Auditory Word Learning Test - Huashan (AVLT-H)

A scale to test memory function in which the tester reads out 12 words after informing the subject that they need to recall them, and the subject recalls, learns, and recalls the words three times in a row immediately after hearing them, short delayed recall, long-delayed recall, categorical cue recall, and recognition, and the number of words recalled is recorded. Higher scores represent better memory.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Montreal cognitive assessment-basic (MOCA-B)

The Montreal Cognitive Assessment-Basic (MoCA-B) assesses the patient's overall cognitive function. The scale is simple and easy to use and covers several cognitive domains, including attention, executive function, memory, language, visuospatial ability, etc. The higher the score, the better the cognitive function.

Time frame
From enrollment to the end of treatment at 12 weeks
3

Verbal fluency test (VFT)

The number of animal names uttered by the participant within 1 minute is recorded. The more the animal' name is spoken, the better the verbal fluency.

Time frame
From enrollment to the end of treatment at 12 weeks
4

The functional Assessment of Cancer Therapy-Cognitive Function(FACT-Cog)

The Assessment of Cognitive Functioning in Cancer Therapy (FACT-Cog) is a comprehensive scale that assesses self-reported cognitive functioning and consists of the following four sections, Perceived Cognitive Impairment (Cog-PCI), Perceived Cognitive Ability (Cog-PCA), Quality of Life Impacted by Cognitive Impairment (Cog-QoL), and Cognitive Impairment as Perceived by Others (Cog-Oth) for a total of 37 items, with a score of 4 points each. Each item is scored out of 4. The higher the score, the better the self-reported cognitive functioning.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: