FrailtyNCT05279625
Effects of Exercise Interventions in Frail Middle-aged and Older Adults
A study testing exercise training in people with Frailty, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Frailty
- What is being tested?
- exercise training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 1 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 50 years old with frailty syndrome
Who cannot join
- Acute illnesses, such as unstable cardiac dysrhythmia, sepsis, or unstable vital signs
- Physical or Cognitive issues that make it difficult for the patients to participate in our program
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch
Yilan
Wang-Sheng Lin, 886-39222141, a8889bms47@gmail.com
About this study
This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.
Read the detailed description
Exercise has been suggested as a possible lifestyle intervention for improving physical and cognitive performance. Various training options depending on various physical circumstances will be presented. However, the ideal exercise protocol for frail middle-aged and older adults had the greater benefits remain unknown. In general, 3-6 months of frequent exercise can enhance physical and cognitive outcome.
The investigators conduct this multiple arm, prospective study to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and cognitive functions. This study designed to recruit 200 older adults with frailty. All the older adults will receive exercise training using either elastic band, dumbbells, machines, treadmill, cycling for 6 months. Outcome measures including a systematic evaluation for frail older persons using comprehensive geriatric assessment, as well as the assessments of physical and cognitive functions before and after interventions.
- Conditions
- Frailty
- Being tested
- exercise training
- Keywords
- exercise, frailty, physical function, mental function, aged
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingDevice
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Interval exercise training | Experimental | Interval exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months Receives: Device: exercise training |
| continuous exercise training | Experimental | continuous exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months Receives: Device: exercise training |
| machine-assisted exercise training | Experimental | machine-assisted exercise training for 6 months Receives: Device: exercise training |
| traditional rehabilitation | Active comparator | traditional rehabilitation for 6 months Receives: Device: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Barthel index
Test function of activities of daily living, range from 0-100, higher values represent a greater outcome.
Measured: Up to 6 months
Change of Montreal Cognitive Assessment
Test cognition including memory, attention, and language, range from 0-30, higher values represent a greater outcome
Measured: Up to 6 months
Change of Geriatric Depression Scale
Test depression status, , range from 0-15, higher values represent a worse outcome
Measured: Up to 6 months
Change of Lawton Instrumental Activities of Daily Living (IADL) Scale
To assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances.y. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
Measured: Up to 6 months
Secondary outcomes (6)
Change of Six-minute Walking Test
Test physical function. In healthy subjects, the 6-min walk distance ranges from 400 to 700 m.
Measured: Up to 6 months
Change of Timed Get-up-and-go Test
Test for quantifying functional mobility
Measured: Up to 6 months
Change of Memory span test
an examiner reads a list of random numbers aloud at about the rate of one number per second. At the end, the person being tested is asked to recall the items, in order.
Measured: Up to 6 months
Change of Color Trails Test
Test cognitive function. Test is scored by how long it takes to complete the test.
Measured: Up to 6 months
Change of Digit symbol substitution test
Test cognitive function. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved.
Measured: Up to 6 months
Change of Mini-mental state examination
Test cognitive function, range from 0-30, higher values represent a greater outcome
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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 randomized, multi-arm parallel and controlled intervention study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wang-Sheng Lin, MD, Principal investigator, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch, Yilan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279625
- Sponsor's protocol ID
- 2021-10-014BCF
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Interventions in Frail Middle-aged and Older Adults
- ClinicalTrials.gov ID
- NCT05279625
- Acronym / sponsor ID
- 2021-10-014BCF
- Conditions
- Frailty
- Keywords
- exercise, frailty, physical function, mental function, aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Mar 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 study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.
Detailed description
Exercise has been suggested as a possible lifestyle intervention for improving physical and cognitive performance. Various training options depending on various physical circumstances will be presented. However, the ideal exercise protocol for frail middle-aged and older adults had the greater benefits remain unknown. In general, 3-6 months of frequent exercise can enhance physical and cognitive outcome.
The investigators conduct this multiple arm, prospective study to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and cognitive functions. This study designed to recruit 200 older adults with frailty. All the older adults will receive exercise training using either elastic band, dumbbells, machines, treadmill, cycling for 6 months. Outcome measures including a systematic evaluation for frail older persons using comprehensive geriatric assessment, as well as the assessments of physical and cognitive functions before and after interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- a randomized, multi-arm parallel and controlled intervention study.
| Arm | Type | Receives |
|---|---|---|
| Interval exercise training | Experimental | Device: exercise trainingInterval exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months |
| continuous exercise training | Experimental | Device: exercise trainingcontinuous exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months |
| machine-assisted exercise training | Experimental | Device: exercise trainingmachine-assisted exercise training for 6 months |
| traditional rehabilitation | Active comparator | Device: exercise trainingtraditional rehabilitation for 6 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged above 50 years old with frailty syndrome
Key exclusion criteria (2 listed)
- Acute illnesses, such as unstable cardiac dysrhythmia, sepsis, or unstable vital signs
- Physical or Cognitive issues that make it difficult for the patients to participate in our program
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 |
|---|---|---|
| exercise trainingusing either elastic band, dumbbells, treadmill, cycling, machines for 6 months | Device | Interval exercise training, continuous exercise training, machine-assisted exercise training, traditional rehabilitation |
Primary outcome
Change of Barthel index
Time frame: Up to 6 months
Test function of activities of daily living, range from 0-100, higher values represent a greater outcome.
Change of Montreal Cognitive Assessment
Time frame: Up to 6 months
Test cognition including memory, attention, and language, range from 0-30, higher values represent a greater outcome
Change of Geriatric Depression Scale
Time frame: Up to 6 months
Test depression status, , range from 0-15, higher values represent a worse outcome
Change of Lawton Instrumental Activities of Daily Living (IADL) Scale
Time frame: Up to 6 months
To assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances.y. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
6 secondary outcomes
Change of Six-minute Walking Test
Time frame: Up to 6 months
Change of Timed Get-up-and-go Test
Time frame: Up to 6 months
Change of Memory span test
Time frame: Up to 6 months
Change of Color Trails Test
Time frame: Up to 6 months
Change of Digit symbol substitution test
Time frame: Up to 6 months
Change of Mini-mental state examination
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Wang-Sheng Lin, MD principal investigator
Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch, Yilan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Frailty, run by Taipei Veterans General Hospital, Taiwan 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 1 inclusion and 2 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 15 Mar 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 Wang-Sheng Lin, MD (+886-39222141, a8889bms47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Barthel index (time frame: Up to 6 months). The study lists 4 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 15 Mar 2022.