Heart DiseasesNCT05245110
Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity
A study testing tele-exercise training in people with Heart Diseases and Type 2 Diabetes, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Diseases, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- tele-exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2018to 31 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout)
- Aged 18-80 years
- Able to speak and understand Mandarin
- Able to walk without assistance
- Had mobile phones and could easily access the Internet
Who cannot join
- Not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
- Not able to speak and understand Mandarin
- Not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability
- Did not have mobile phones or could not access the internet at home and whenever necessary
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chia-Huei Lin
Taipei, Hawaii, 11105
Chia-Huei Lin, PhD, +8862785116, andyy520@yahoo.com.tw
Shang-Lin Chiang, PhD, +8862785116, andyyy520@yahoo.com.tw
About this study
Official title: Tri-Service General Hospital, National Defense Medical Center
This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.
Read the detailed description
A parallel-group randomized controlled trial was conducted. Eligible patients with cardiometabolic multimorbidity were randomized 1:1 to either experimental group (EG, received a tele-exercise training program) or control group (CG, usual care only). The intervention encompassed tele-exercise training program (30 min/session, 3 sessions/week) and weekly remote monitoring for maintenance of exercise. Physical activity and cardiorespiratory fitness were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group.
- Conditions
- Heart Diseases, Type 2 Diabetes, Metabolic Syndrome, Coronary Artery Disease, Heart Failure
- Being tested
- tele-exercise training
- Keywords
- exercise, physical activity, cardiorespiratory fitness
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, Type 2, Metabolic Syndrome, Coronary Artery Disease, Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-exercise trainingBehavioural
a 12-week tele-exercise training program
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | received a tele-exercise training program Receives: Behavioral: tele-exercise training |
| control group | No intervention | usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline physical activity amount at 12 weeks
weekly amount of physical activity using the well-validated and reliable Taiwan version of 7-item International Physical Activity Questionnaire to measure. The scores of International Physical Activity Questionnaire expressed as "MET-minutes/week". Higher score indicates higher physical activity amounts
Measured: 12 weeks
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
VO2 peak (ml/kg/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline workload (Watts)at 12 weeks
Workload (Watts), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline anaerobic threshold at 12 weeks
anaerobic threshold, detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline O2 pulse (ml/beat) at 12 weeks
O2 pulse (ml/beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline One-min heart rate recovery (beat) at 12 weeks
One-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
Two-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline resting heart rate (bpm) at 12 weeks
Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)
Measured: 12 weeks
Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)
Measured: 12 weeks
Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)
Measured: 12 weeks
Changes from baseline forced vital capacity (L/min) at 12 weeks
forced vital capacity (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
forced expiratory volume in one second (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline FEV1/FVC (%) at 12 weeks
FEV1/FVC (%) detected during graded exercise testing, , performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Measured: 12 weeks
Changes from baseline Ejection fraction (%) at 12 weeks
Ejection fraction (%) data were collected through chart review
Measured: Baseline and 12 weeks
Changes from baseline BNP at 12 weeks
BNP through blood analysis
Measured: 12 weeks
Changes from baseline Health-related quality of life at 12 weeks
Health-related quality of life useing the reliable and valid Taiwan version of Medical Outcomes Study Short-Form 36 to measure. Scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Apr 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, CHIA-HUEI LIN, PhD, Tri-Service General Hospital (TSGH)
- Investigators
- Chia-Huei Lin, PhD, Principal investigator, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245110
- Sponsor's protocol ID
- TSGHIRB: 1-106-05-107
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-Service General Hospital, National Defense Medical Center
- ClinicalTrials.gov ID
- NCT05245110
- Acronym / sponsor ID
- TSGHIRB: 1-106-05-107
- Conditions
- Heart Diseases, Type 2 Diabetes, Metabolic Syndrome, Coronary Artery Disease, Heart Failure
- Keywords
- exercise, physical activity, cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.
Detailed description
A parallel-group randomized controlled trial was conducted. Eligible patients with cardiometabolic multimorbidity were randomized 1:1 to either experimental group (EG, received a tele-exercise training program) or control group (CG, usual care only). The intervention encompassed tele-exercise training program (30 min/session, 3 sessions/week) and weekly remote monitoring for maintenance of exercise. Physical activity and cardiorespiratory fitness were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: tele-exercise trainingreceived a tele-exercise training program |
| control group | No intervention | –usual care only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout)
- Aged 18-80 years
- Able to speak and understand Mandarin
- Able to walk without assistance
- Had mobile phones and could easily access the Internet
Key exclusion criteria (4 listed)
- Not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
- Not able to speak and understand Mandarin
- Not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability
- Did not have mobile phones or could not access the internet at home and whenever necessary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-exercise traininga 12-week tele-exercise training program | Behavioural | experimental group |
Primary outcome
Changes from baseline physical activity amount at 12 weeks
Time frame: 12 weeks
weekly amount of physical activity using the well-validated and reliable Taiwan version of 7-item International Physical Activity Questionnaire to measure. The scores of International Physical Activity Questionnaire expressed as "MET-minutes/week". Higher score indicates higher physical activity amounts
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
Time frame: 12 weeks
VO2 peak (ml/kg/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline workload (Watts)at 12 weeks
Time frame: 12 weeks
Workload (Watts), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline anaerobic threshold at 12 weeks
Time frame: 12 weeks
anaerobic threshold, detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline O2 pulse (ml/beat) at 12 weeks
Time frame: 12 weeks
O2 pulse (ml/beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline One-min heart rate recovery (beat) at 12 weeks
Time frame: 12 weeks
One-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
Time frame: 12 weeks
Two-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline resting heart rate (bpm) at 12 weeks
Time frame: 12 weeks
Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
Time frame: 12 weeks
Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
Time frame: 12 weeks
Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline forced vital capacity (L/min) at 12 weeks
Time frame: 12 weeks
forced vital capacity (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
Time frame: 12 weeks
forced expiratory volume in one second (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline FEV1/FVC (%) at 12 weeks
Time frame: 12 weeks
FEV1/FVC (%) detected during graded exercise testing, , performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline Ejection fraction (%) at 12 weeks
Time frame: Baseline and 12 weeks
Ejection fraction (%) data were collected through chart review
Changes from baseline BNP at 12 weeks
Time frame: 12 weeks
BNP through blood analysis
Changes from baseline Health-related quality of life at 12 weeks
Time frame: 12 weeks
Health-related quality of life useing the reliable and valid Taiwan version of Medical Outcomes Study Short-Form 36 to measure. Scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Huei Lin, PhD principal investigator
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-exercise training in people with Heart Diseases and Type 2 Diabetes, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 4 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chia-Huei Lin, PhD (+886-920328195, andyy520@mail.ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline physical activity amount at 12 weeks (time frame: 12 weeks). The study lists 16 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 17 Feb 2022.