Nutrition and Exercise Program for Elderly Colorectal Cancer Patients

September 12, 2025 updated by: Ching-Ching Su, Chang Gung University of Science and Technology

Effects of the Tailored Frailty Prevention Program With Exercise and Nutrition Management to Improve Physical Performance and Health Status in Older Patients With Colorectal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • Physical activities are accessible.
  • Those who have a smartphone and have experience using smartphones.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nutrition combined with exercise group
Provide mobile health interventions that combine nutrition and exercise
Behavioral: Mobile Health Management Frailty Care Program
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.
No Intervention: routine care group
Provide routine care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention
Physical Activity
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention
Nutritional Status
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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
Pre-test, sixth week after intervention, 13th week after intervention
Depression
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention
body mass index
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention
hand grip strength
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
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.
Pre-test, sixth week after intervention, 13th week after intervention
walking speed
Time Frame: Pre-test, sixth week after intervention, 13th week after intervention
Walking speed was measured with a 4-meter walking evaluation with a static start. The 4-m gait speed was assessed to the nearest 0.01 s using a stopwatch. Participants were instructed to walk at their comfortable speed. Walking distance exceeded the required four meters to prevent participants from slowing down before reaching the 4-m line. The fastest time of two trials was used for analyses and gait speed was expressed in m/s. The 0.8 m/s cut-point was used to represent a slow walking speed.
Pre-test, sixth week after intervention, 13th week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ching-Ching Su, PhD, Chang Gung University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202300957B0C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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