Research on remote exercise support for esophageal cancer patients

JRCT ID: jRCT1062220049

Registered date:20/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 01/08/2022
• Target sample size: 58
• Study type: Interventional

Intervention(s)

Duration of hospitalization
Standard preoperative rehabilitation (stretching, aerobic exercise, resistance exercise, breathing exercises) under the supervision of a physical therapist. Patients will be instructed on the use of an accelerometer.

Duration at home
The patient is instructed individually to perform stretching, breathing exercises, aerobic exercise, and resistance exercise on their own. In aerobic exercise, set targets for the number of steps and moderate-intensity physical activity individually. The moderate-intensity level will be set based on subjective symptoms, pulse rate, and the results of a 6-minute walk test. The patients will be required to wear an accelerometer every day during the outpatient period to check whether they are achieving their goals or not remotely. Exercise will be modified by telephone once a week. The intervention will be considered as long as the patient wears the device at least 3 times a week for 300 minutes/day, and if the patient does not wear the device for more than 2 days, he/she will be encouraged to wear it.

Outcome(s)

• Primary Outcome: 6-minute walking distance

Secondary Outcome

Lower limb muscle strength
Respiratory muscle strength
Muscle mass
Extracellular water ratio
Ability to perform activities of daily living
Quality of life
Physical activity
Malnutrition
Adherence
adverse events
Post-operative indicators
Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients diagnosed with esophageal cancer cStage 1-4a (Union for International Cancer Control criteria) and undergoing preoperative chemotherapy
Male and female patients aged 20 years or older and 80 years or younger at the time of consent.
Two courses of three drugs (docetaxel, cisplatin, and fluorouracil) will be administered as neoadjuvant chemotherapy.

Exclude criteria

Diagnosed with dementia
Needs assistance in walking or moving around.
Patients undergoing treatment other than chemotherapy such as radiation therapy
Patients who are judged to be inappropriate as research subjects by the principal investigator and research coordinators.
Patients who are prohibited from exercise therapy by the attending physician due to complications such as serious cardiac or renal disease.

Related Information

• Primary Sponsor: Noma Tomohiro