Nutrition and Exercise Program for Elderly Colorectal Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChang Gung University of Science and Technology

About this trial

The goal of this interventional study is to evaluate the effect of mobile health intervention on frailty, physical fitness, physical activity, and nutritional status of elderly patients with colorectal cancer. The main questions it aim to answer are: 1. Does the mobile health intervention reduce frailty in elderly colorectal cancer patients compared to standard care? 2. Does the mobile health intervention improve physical fitness, physical activity, and nutritional status in elderly colorectal cancer patients compared to standard care? Participants will receive the Mobile Health Management Frailty Care Program.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with colorectal cancer confirmed by a physician.

Aged 60 and above.

Have communication skills, able to read and write or converse in Mandarin and Taiwanese.

Clear consciousness and no mental or cognitive impairment.

Disqualifiers

People who have difficulty walking or standing.

The wrist is not suitable for those wearing sports bracelets.

People in infectious or protective isolation.

Those who live alone or in institutions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobile Health Management Frailty Care Program

    Behavioral

    Through the "LINE" communication software, participants are provided with exercise and nutrition information three times a week, with a total of 36 messages. As well as 6 podcasts of health information and 6 sports videos in total. At weeks 2, 4, and 6, researchers scheduled 5- to 10-minute telephone consultations. Participants can receive guidance through telephone consultations and carry a Xiaomi sports band wearable device to monitor their exercise.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Nutrition combined with exercise groupExperimental treatment 1 intervention
Group B: routine care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Frailty

Assessing frailty status using the G8 geriatric screening tool. Scores range from 0 to 17, with 0 indicating severe impairment and 17 indicating no impairment. The lower the score, the more frail it is.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention
2

Physical Activity

Assess physical activity with the International Physical Activity Questionnaire-Short Form. The IPAQ-SF evaluates the number of days and time spent performing MVPA, walking, and sitting in bouts of at least 10 min over the previous 7 days. The summary score is expressed in PA metabolic equivalent of task (MET)-min per day or week.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention
3

Nutritional Status

Assess nutritional status with Mini Nutritional Assessment-Short Form. The total score is 0-14 points. A score of 12 or more indicates a low risk of malnutrition. A score of 8-11 indicates a potential risk of malnutrition. A score less than 7 indicates a high risk of malnutrition.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention

Secondary outcomes

1

health-related quality of life

Assessing quality of life using Taiwan Chinese version of European Organization for Research and Treatment of Cancer questionnaires. For all scales, item scores are summed and linearly transformed into a scale ranging from 0 to 100. Higher scores on the functioning scales indicate higher levels of functioning

Time frame
Pre-test, sixth week after intervention, 13th week after intervention
2

Depression

Assessing depression level using the Geriatric Depression Scale Short Form. The higher the score, the higher the degree of depression. 0-4 indicates normal, 5-10 indicates slight tendency to depression, and 10 or more indicates symptoms of depression.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention
3

body mass index

Body mass index is calculated by dividing weight (kg) by height (meters) squared. The normal range is 18.5 ≦ BMI \< 24. Less than 18.5 represents underweight; 24 ≦ BMI \<27 represents overweight; 27 ≦ BM I\<30 represents mild obesity; 30 ≦ BMI \<35 represents moderate obesity; BMI ≧35 represents severe obesity.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention
4

hand grip strength

Hand grip strength (in kilograms) was measured using a digital hand dynamometer (EH101; Camry, Guangdong Province, China). The grip strength of the dominant hand was assessed three times, and the maximal value was considered for analysis. The definition of normal GS according to European Working Group on Sarcopenia in Older People (EWGSOP) was ≥ 30kg in the male and ≥ 20 kg in the female. Weak GS was defined as GS \< 30 kg in the male and GS \< 20 kg in the female.

Time frame
Pre-test, sixth week after intervention, 13th week after intervention

Other outcomes

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