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Walking InterventionNCT05696262

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

A study testing 6-walking program in people with Walking Intervention, run by Taipei Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Walking Intervention
What is being tested?
6-walking program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
16 Jan 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • unable to have normal conversation due to illness.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Being tested
6-walking program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-walking programBehavioural

    Perform 6 minutes of walking exercise 3 times a day, 3 days a week, in a comfortable manner

Study groups in NCT05696262
Study groupRoleWhat they receive
6-walking programExperimentalPerform 6 minutes of walking exercise 3 times a day, 3 days a week, in a comfortable manner.
Receives: Behavioral: 6-walking program
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steps count

    exercise outcome using pedometer

    Measured: Change from Baseline post exercise 5 min

  2. Steps count

    exercise outcome using pedometer

    Measured: Change from Baseline at 6 month.

Secondary outcomes (10)
  1. Depression--Patient Health Questionnaire (PHQ-9)

    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.

    Measured: Change from Baseline post exercise 5 min

  2. Depression--Patient Health Questionnaire (PHQ-9)

    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.

    Measured: Change from Baseline at 6 month.

  3. cancer fatigue--BFI

    severity of fatigue level; measurement tool: Brief Fatigue Index

    Measured: Change from Baseline post exercise 5 min

  4. cancer fatigue--BFI

    severity of fatigue level; measurement tool: Brief Fatigue Index

    Measured: Change from Baseline at 6 month.

  5. Quality of Life--EQ5D-5L

    a 5-digit number that describes the patient's health state. The score increase means good quality of life.

    Measured: baseline and six month.

  6. Symptom Assessment---Chinese version of the Edmonton Symptom Assessment System,C-ESAS

    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.

    Measured: baseline

  7. Symptom Assessment---Chinese version of the Edmonton Symptom Assessment System,C-ESAS

    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.

    Measured: Change from Baseline at 6 month.

  8. Smart bracelet_Heart rate variability (HRV)

    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.

    Measured: Continue wear bracelet five days to record HRV data.

  9. Trial Outcome Index (TOI)

    TOI is a useful tool to assess the physical and functional effects of treatment in patients. The higher score means higher outcome.

    Measured: Change from Baseline post exercise 5 min

  10. Trial Outcome Index (TOI)

    TOI is a useful tool to assess the physical and functional effects of treatment in patients. The higher score means higher outcome.

    Measured: Change from Baseline at 6 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start16 Jan 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696262
Sponsor's protocol ID
N202207044
Status last verified
Jan 2023
First submitted
15 Nov 2022
Last updated
25 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 6-walking program in people with Walking Intervention, run by Taipei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tsai-Wei Huang, PhD (+886-2-27361661 ext. 6350, tsaiwei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps count (time frame: Change from Baseline post exercise 5 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.

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