OsteoporosisNCT02017067
The Effect of Exercise Training in the Community-dwelling Adults With Chronic Disorders
A study testing hydraulic resistance circuit training in people with Osteoporosis and Osteoarthritis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Previous studies have demonstrated that resistance training (RT) is beneficial to increase muscle strength, improve functional ability and the ability to rapidly produce force, known as the contractile rate of force development (RFD) in older adults. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteoarthritis
- What is being tested?
- hydraulic resistance circuit training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Sep 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
- 45 years old or older; (2) diagnosed by a physician with osteoporosis (or osteopenia) or/and osteoarthritis; (3) able to participate safely in a moderately vigorous program of physical activity; (4) not previously taken part in any type of resistance training but were all physically capable of entering exercise.
Who cannot join
- a acute or terminal illness, myocardial infarction within 6 months (or other symptomatic coronary artery disease); (2) uncontrolled hypertension (> 150/90 mmHg); (3) fracture in the previous 6 months; (3) diseases or medication affecting neuromuscular function; (4) physical limitation in sports and were advised not to exercise by doctors.
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have demonstrated that resistance training (RT) is beneficial to increase muscle strength, improve functional ability and the ability to rapidly produce force, known as the contractile rate of force development (RFD) in older adults. However, much less research has focused on the effect of RT on the lower extremity muscle strength, contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of this study was to investigate the effect of RT on the lower extremity muscle strength, RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for OP and knee OA (KOA). The investigators hypothesized that such a training program would lead to induce not only specific muscle strength enhancement but also an increment in contractile RFD and impulse.
Read the detailed description
Osteoporosis (OP) and osteoarthritis (OA) are the two most common musculoskeletal conditions in older adults, causing high healthcare costs and negative effects on quality of life. Previous studies have reported that OP and OA has a strong association with sarcopenia, a term defined as age-related involuntary loss of skeletal muscle mass and strength or function.A decline of muscle mass and strength in older adults may limit a variety of activities of daily living (ADLs) and increase morbidity and mortality. However, many ADLs often involve faster limb movements with contraction times of 50 - 200 ms (i.e. sit-to-stand performance and avoiding falls). Therefore, in addition to muscle mass and strength, the ability to rapidly produce force, known as the contractile rate of force development (RFD), and the area under the force-time curve, defined as contractile impulse, seem to be important to adequately characterize the performance of ADLs in older adults. Typically, resistance training (RT) is often prescribed to increase muscle strength, improve functional ability and eliminate much of age-associated muscle atrophy and weakness in a healthy population. Other studies have also shown that implementation of RT can help improve RFD in healthy young and elderly individuals following RT. However, it still unclear that the effect of RT on contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions. Therefore, the aim of this study was to examine the effects on the lower extremity muscle strength, contractile rate of force development (RFD), impulse in middle-aged and older people with osteoporosis (OP)(or osteopenia) or knee osteoarthritis (KOA) after 12 weeks of resistance training.
- Conditions
- Osteoporosis, Osteoarthritis
- Being tested
- hydraulic resistance circuit training
- Keywords
- Resistance training, musculoskeletal conditions, RFD
- Medical subject headings
- Osteoporosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydraulic resistance circuit trainingProcedure or surgery
12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 7 types of equipments for different part of strength training.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Maintain regular physical activity as usual, and received health education material about their disease, importance of nutrition and risks factors. |
| hydraulic resistance circuit training | Experimental | 12 weeks resistance training Receives: Procedure: hydraulic resistance circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary contraction (MVC)
Muscle strength was measured as maximum voluntary contraction (MVC) of the quadriceps exerted on an isokinetic dynamometer.
Measured: three months
Secondary outcomes (2)
Contractile rate of force development (RFD)
Contractile rate of force development (RFD) was derived as the average slope of the initial phase of the torque-time curve (change in torque/change in time) at 0-30, 50, 100, and 200 ms relative to the onset of contraction.
Measured: three months
Impulse
Contractile impulse was determined as the area under the torque -time curve in the same time intervals of 0-30, 0-50, 0-100, and 0-200 ms relative to the onset of contraction.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT02017067
- Sponsor's protocol ID
- FEMH-IRB-101020-E
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training in the Community-dwelling Adults With Chronic Disorders
- ClinicalTrials.gov ID
- NCT02017067
- Acronym / sponsor ID
- FEMH-IRB-101020-E
- Conditions
- Osteoporosis, Osteoarthritis
- Keywords
- Resistance training, musculoskeletal conditions, RFD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Dec 2013 (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.
Previous studies have demonstrated that resistance training (RT) is beneficial to increase muscle strength, improve functional ability and the ability to rapidly produce force, known as the contractile rate of force development (RFD) in older adults. However, much less research has focused on the effect of RT on the lower extremity muscle strength, contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of this study was to investigate the effect of RT on the lower extremity muscle strength, RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for OP and knee OA (KOA). The investigators hypothesized that such a training program would lead to induce not only specific muscle strength enhancement but also an increment in contractile RFD and impulse.
Detailed description
Osteoporosis (OP) and osteoarthritis (OA) are the two most common musculoskeletal conditions in older adults, causing high healthcare costs and negative effects on quality of life. Previous studies have reported that OP and OA has a strong association with sarcopenia, a term defined as age-related involuntary loss of skeletal muscle mass and strength or function.A decline of muscle mass and strength in older adults may limit a variety of activities of daily living (ADLs) and increase morbidity and mortality. However, many ADLs often involve faster limb movements with contraction times of 50 - 200 ms (i.e. sit-to-stand performance and avoiding falls). Therefore, in addition to muscle mass and strength, the ability to rapidly produce force, known as the contractile rate of force development (RFD), and the area under the force-time curve, defined as contractile impulse, seem to be important to adequately characterize the performance of ADLs in older adults. Typically, resistance training (RT) is often prescribed to increase muscle strength, improve functional ability and eliminate much of age-associated muscle atrophy and weakness in a healthy population. Other studies have also shown that implementation of RT can help improve RFD in healthy young and elderly individuals following RT. However, it still unclear that the effect of RT on contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions. Therefore, the aim of this study was to examine the effects on the lower extremity muscle strength, contractile rate of force development (RFD), impulse in middle-aged and older people with osteoporosis (OP)(or osteopenia) or knee osteoarthritis (KOA) after 12 weeks of resistance training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Maintain regular physical activity as usual, and received health education material about their disease, importance of nutrition and risks factors. |
| hydraulic resistance circuit training | Experimental | Procedure: hydraulic resistance circuit training12 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)
- 45 years old or older; (2) diagnosed by a physician with osteoporosis (or osteopenia) or/and osteoarthritis; (3) able to participate safely in a moderately vigorous program of physical activity; (4) not previously taken part in any type of resistance training but were all physically capable of entering exercise.
Key exclusion criteria (1 listed)
- a acute or terminal illness, myocardial infarction within 6 months (or other symptomatic coronary artery disease); (2) uncontrolled hypertension (> 150/90 mmHg); (3) fracture in the previous 6 months; (3) diseases or medication affecting neuromuscular function; (4) 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 7 types of equipments for different part of strength training. | Procedure or surgery | hydraulic resistance circuit training |
Primary outcome
Maximum voluntary contraction (MVC)
Time frame: three months
Muscle strength was measured as maximum voluntary contraction (MVC) of the quadriceps exerted on an isokinetic dynamometer.
2 secondary outcomes
Contractile rate of force development (RFD)
Time frame: three months
Impulse
Time frame: three months
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 20 Dec 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 Osteoporosis and Osteoarthritis, 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 20 Dec 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?
Maximum voluntary contraction (MVC) (time frame: three months). 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 20 Dec 2013.