DiabetesNCT01754415
Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community
A study testing hydraulic resistance circuit training in people with Diabetes and Hypertension, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to evaluate the effect of hydraulic resistance circuit training for elderly people with chronic illness. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Osteoporosis
- What is being tested?
- hydraulic resistance circuit training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to May 2013
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects were recruited at the age of 45-80, and can communicate verbally and in writing.
Who cannot join
- Subjects had physical limitation in sports and were advised not to exercise by doctors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community.
The aim of this study is to evaluate the effect of hydraulic resistance circuit training for elderly people with chronic illness.
Read the detailed description
This study is divided into three years. The aim of the first year is to analyze the types and percentage of chronic illness in middle- and old-aged population in communities and the impact on their physical and mental function. The Second year, we will use proper exercise prescriptions with exercise equipment available for chronic illness population and examine the improvement of their physical and mental functions after exercise intervention. The third year, we will adopt the concept of social marketing to promote knowledge about health-related fitness and exercise to communities and help to establish exercise center. To chronic illness people, the study seeks to delay the progression of disease and disability by encouraging them to participate in prescribed exercises. To relatively healthy people, exercise can achieve the purposes of healthy aging, decreased chronic illness, and improved ADLs function and life quality.
- Conditions
- Diabetes, Hypertension, Osteoporosis, Osteoarthritis
- Being tested
- hydraulic resistance circuit training
- Keywords
- Aging, Chronic illness, Resistance circuit training
- Medical subject headings
- Diabetes Mellitus, Hypertension, Osteoporosis, Osteoarthritis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydraulic resistance circuit trainingDevice
12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 10 types of equipments for different part of strength training.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Do exercise at home with video program designed by our team. |
| hydraulic resistance circuit training | Experimental | Intervention:12 weeks resistance training Receives: Device: hydraulic resistance circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ)
Level of self-reported physical activity assessed with the International Physical Activity Questionnaire,IPAQ and expressed as MET-minutes.
Measured: three years
Secondary outcomes (2)
Body composition measurement
Body composition refers to the amount of relative fat to muscle you have in your body, which the items include height (cm), weight(kg), body mass index (BMI), muscle mass(kg), fat (%), fat mass, fat free mass (FFM), and total body water (TBW).
Measured: three years
The physical fitness assessment
The physical fitness designed to evaluate several components of functional fitness was as follows:
30-second chair stand test: Count the times that person rises in 30-s without pushing off with the arms.
Chair sit and reach: Measure the distance with an 20-cm ruler that a person is short of reaching the toe (minus score) or beyond the toe (plus score).
2-minute step test: Determine the times that person can step in place, raising (Alternate test) the knees to a height halfway between the iliac crest and middle of the patella, in 2-min.
Back scratch: Measure the distance between (or the overlap of) the middle fingers behind the back when trying to touch the middle fingers of both hands together behind the back.
8-foot up and go: Measure the time it takes to get out of a chair, walk 8-feet to and around a cone, and return to the chair.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Ching Lin, Master, Study chair, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754415
- Sponsor's protocol ID
- FEMH-IRB-098101-3
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2012
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community.
- ClinicalTrials.gov ID
- NCT01754415
- Acronym / sponsor ID
- FEMH-IRB-098101-3
- Conditions
- Diabetes, Hypertension, Osteoporosis, Osteoarthritis
- Keywords
- Aging, Chronic illness, Resistance circuit training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Dec 2012 (estimated)
- 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.
The aim of this study is to evaluate the effect of hydraulic resistance circuit training for elderly people with chronic illness.
Detailed description
This study is divided into three years. The aim of the first year is to analyze the types and percentage of chronic illness in middle- and old-aged population in communities and the impact on their physical and mental function. The Second year, we will use proper exercise prescriptions with exercise equipment available for chronic illness population and examine the improvement of their physical and mental functions after exercise intervention. The third year, we will adopt the concept of social marketing to promote knowledge about health-related fitness and exercise to communities and help to establish exercise center. To chronic illness people, the study seeks to delay the progression of disease and disability by encouraging them to participate in prescribed exercises. To relatively healthy people, exercise can achieve the purposes of healthy aging, decreased chronic illness, and improved ADLs function and life quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Do exercise at home with video program designed by our team. |
| hydraulic resistance circuit training | Experimental | Device: hydraulic resistance circuit trainingIntervention:12 weeks resistance training |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects were recruited at the age of 45-80, and can communicate verbally and in writing.
Key exclusion criteria (1 listed)
- Subjects had physical limitation in sports and were advised not to exercise by doctors.
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 |
|---|---|---|
| hydraulic resistance circuit training12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 10 types of equipments for different part of strength training. | Device | hydraulic resistance circuit training |
Primary outcome
International Physical Activity Questionnaire (IPAQ)
Time frame: three years
Level of self-reported physical activity assessed with the International Physical Activity Questionnaire,IPAQ and expressed as MET-minutes.
2 secondary outcomes
Body composition measurement
Time frame: three years
The physical fitness assessment
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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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.
Tsung-Ching Lin, Master study chair
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydraulic resistance circuit training in people with Diabetes and Hypertension, run by Far Eastern Memorial Hospital 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 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: finished, as of the sponsor's last update on 15 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (IPAQ) (time frame: three years). 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 Nov 2013.