6 Minutes Walking Program for Terminally Ill Patients at Home or in an Institution

January 23, 2023 updated by: Tsai-Wei Huang, Taipei Medical University

Effects of 6-minute Walking Exercise in Advanced Cancer and Non-cancer Patients: a Randomized Controlled Trial

This study was conducted with a single-blind, randomized control method for 120 participants, 60 in the regular care group and 60 in the exercise intervention group. Those who meet the admission criteria will be contacted by phone and explained the purpose of the study. After asking for and obtaining consent, those who are willing to sign the consent form will be divided into groups and go to the home with the home care worker for the study. A suitable space was arranged for a 6-minute explanation and demonstration of walking exercise and a structured questionnaire to be filled out by the participant (the Barr's scale, Koch's scale and cognitive function assessment in the basic data were filled out by the facilitator), and the facilitator accompanied the participant during the process, giving explanations for unclear points to facilitate the completion of the questionnaire and to achieve a valid questionnaire. A trained research assistant was responsible for recruiting cases and receiving a study number and corresponding group assignment. Stratified random assignment (1:1) was used to divide the exercise intervention group and the usual care group. The study was listed using a randomized use of replacement blocks (block size 4). The assignment sequence was only available to the program facilitator and was not known to the other staff. Interventional measures Routine care group: A primary care team of physicians and nurse practitioners visited at least once a month for: (1) an initial intake visit (60-90 minutes) to provide a holistic assessment of disease intensity and prognosis, psychological distress, and social support; (2) at least one home care visit per month (30-60 minutes); (3) a telephone (4) Provide caregivers with social software and telepresence to solve caregiving problems (5) Provide exercise diaries to record daily activities of daily living (including vital signs, mobility, and fatigue). Exercise intervention group: In addition to the regular care group model, the intervention measure: 6 minute walk test (6MWT) is the simplest and most cost effective way to assess exercise. Pre-intervention equipment: 6-minute walk exercise video, yardstick, distance marker cone, measuring tape, exercise diary, smart bracelet, all subjects were provided with 6-minute walk exercise video and related equipment by the facilitator at intake. Before the test: explain the pre and post-test precautions, demonstrate the correct way to perform the test, and inform the patient to perform the test in a comfortable manner. In addition, the case was asked to wear the bracelet 24 hours a day for 7 days a week to observe the sleep quality. During the intervention period, if a case has the following conditions, the principle of implementation is as follows: (1) if the case has good walking ability, the case will be reminded to comply with the intervention (or keep the original physical activity) through telephone care and exercise diary; (2) if the case is physically able to walk but has low willingness to perform the 6-minute walk due to various conditions, the case will be reminded by family members or followed up by the researcher by telephone to improve the implementation rate; (3) if the case has difficulty getting out of bed due to the progress of the disease or treatment factors. (3) Cases with difficulty in getting out of bed or at risk of falling due to the progress of the disease or treatment factors; (4) Cases using oxygen to walk for 6 minutes in the area of the oxygen nasal cannula and tubing; if there is a risk of falling or injury during the procedure, please stop all activities immediately and ask the caregiver to monitor the vital signs and notify the facilitator and home care provider. If the patient needs to be taken to the hospital for treatment, assist in contacting the ambulance and send to the nearest hospital or the hospital where the patient usually goes for treatment; the host will visit the hospital and understand the situation and fill in the abnormal events. Outcome measurement: The family, primary caregiver, and the case are instructed to correctly measure the number of laps, distance, time, and number of times to walk, and to give instructions. Outcome measures were collected by the co-facilitators at intake, month 1, month 2, month 3, and month 6, and all data and assessment scales were tracked.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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 (Anticipated)

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.
120

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.

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. advanced cancer (cancer stage III or IV)
  2. terminal ill disease
  3. aged >=20 years
  4. ECOG stage 0-3
  5. Life expectancy =< 12 months

Exclusion Criteria:

  1. unable to have normal conversation due to illness.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: Usual care
Experimental: 6-walking program
Perform 6 minutes of walking exercise 3 times a day, 3 days a week, in a comfortable manner.
Behavioral: 6-walking program
Perform 6 minutes of walking exercise 3 times a day, 3 days a week, in a comfortable manner

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
Steps count
Time Frame: Change from Baseline post exercise 5 min
exercise outcome using pedometer
Change from Baseline post exercise 5 min
Steps count
Time Frame: Change from Baseline at 6 month.
exercise outcome using pedometer
Change from Baseline at 6 month.

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
Smart bracelet_Heart rate variability (HRV)
Time Frame: Continue wear bracelet five days to record HRV data.
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.
Continue wear bracelet five days to record HRV data.
cancer fatigue--BFI
Time Frame: Change from Baseline post exercise 5 min
severity of fatigue level; measurement tool: Brief Fatigue Index
Change from Baseline post exercise 5 min
Depression--Patient Health Questionnaire (PHQ-9)
Time Frame: Change from Baseline post exercise 5 min
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. high score mean higher emotion distress.
Change from Baseline post exercise 5 min
Depression--Patient Health Questionnaire (PHQ-9)
Time Frame: Change from Baseline at 6 month.
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. high score mean higher emotion distress.
Change from Baseline at 6 month.
cancer fatigue--BFI
Time Frame: Change from Baseline at 6 month.
severity of fatigue level; measurement tool: Brief Fatigue Index
Change from Baseline at 6 month.
Quality of Life--EQ5D-5L
Time Frame: baseline and six month.
a 5-digit number that describes the patient's health state. The score increase means good quality of life.
baseline and six month.
Symptom Assessment---Chinese version of the Edmonton Symptom Assessment System，C-ESAS
Time Frame: baseline
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
baseline
Symptom Assessment---Chinese version of the Edmonton Symptom Assessment System，C-ESAS
Time Frame: Change from Baseline at 6 month.
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Change from Baseline at 6 month.
Trial Outcome Index (TOI)
Time Frame: Change from Baseline post exercise 5 min
TOI is a useful tool to assess the physical and functional effects of treatment in patients. The higher score means higher outcome.
Change from Baseline post exercise 5 min
Trial Outcome Index (TOI)
Time Frame: Change from Baseline at 6 month.
TOI is a useful tool to assess the physical and functional effects of treatment in patients. The higher score means higher outcome.
Change from Baseline at 6 month.

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.
Taipei Medical University

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 (Anticipated)

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.
January 16, 2023

Primary Completion (Anticipated)

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.
December 31, 2025

Study Completion (Anticipated)

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.
December 31, 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).
November 15, 2022

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.
January 23, 2023

First Posted (Estimate)

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.
January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

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.
January 24, 2023

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.
January 23, 2023

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.
January 1, 2023

More Information

Terms related to this study

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.
  • N202207044

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

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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