Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle StrengthNCT04647617
Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.
A study testing Quantitative weight -bearing and report exercise sign data every weekly in people with Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength, run by Yu- Hsuan Chien at 1 site in Taiwan.
Trial summary
According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength
- What is being tested?
- Quantitative weight -bearing and report exercise sign data every weekly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2020to 31 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 50 ~80 years
- T2DM
- Physician and check Calf circumference (M: <34 cm, F: <33 cm)、handgrip strength (M: <28 kg, F: <18 kg)
Who cannot join
- Inability to perform any self -activity
- DM with lower limb neuropathy, r
- DM with Retinopathy
- Stroke
- Foot opening wound
- Past history even doing limb resistance training;
- Easy fall down high risk patients
Trial locations and contacts
1 site in 1 country.
About this study
According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health.
Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.
Read the detailed description
Purpose:This study aim is effectiveness of 12 weeks quantitative weight-bearing progressive exercise training in patients with type 2 diabetes mellitus(T2DM) with pre-sarcopenia promotion muscle strength and blood sugar control.
Hypothesis:After 12 weeks of quantitative sandbag training , the experimental group can have a significant increase in the muscle mass of the upper and lower limbs、grip strength、5-time chair stand test、Lipid profile、glycemic control(HbA1c) and quality of life.
Methods:This study will be a randomized controlled trial. Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Conditions:The effectiveness of 12 weeks quantitative weight-bearing can improvement of Glycemic control and limb muscle strength.
- Being tested
- Quantitative weight -bearing and report exercise sign data every weekly
- Keywords
- Resistance training；Muscle strength；Glycemic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative weight -bearing and report exercise sign data every weeklyBehavioural
Also called Self-manage
keep their normal live style
| Study group | Role | What they receive |
|---|---|---|
| Quantitative Weight-bearing | Experimental | Experimental wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Receives: Behavioral: Quantitative weight -bearing and report exercise sign data every weekly |
| Control group | Placebo comparator | They are keep their normal live style Receives: Behavioral: Quantitative weight -bearing and report exercise sign data every weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
follow blood glucose control
Measured: up to 12 week of invention
muscle strength
follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength
Measured: up to 12 weeks of intervention
muscle mass
Use BIA(Bioelectrical impedance analysis)follow muscle mass,
Measured: up to 12 weeks of invention
5-time chair stand test
follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability
Measured: up to 12 weeks of invention
Secondary outcomes (1)
WHOQOL-BREF World Health Organization Quality of Life Taiwan version
follow T2DM with pre-sarcopenia quality of life. The Questionnaire include four domain: psychological domain, social domain, environment domain and Taiwan local domain.This questionnaire scale higher is more better
follow T2DM with pre-sarcopenia
Measured: up to 12 week of invention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start24 Aug 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle StrengthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12\~15 Repetitions/set X 5 set X 3day.control group keep normal lives
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu- Hsuan Chien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu- Hsuan Chien, Chang Gung Memorial Hospital
- Investigators
- Chia-Jen Tsai, Study director, Kaohsiung Chang Gung Medication Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647617
- Sponsor's protocol ID
- 202001276B0
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage, and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.
- ClinicalTrials.gov ID
- NCT04647617
- Acronym / sponsor ID
- 202001276B0
- Keywords
- Resistance training；Muscle strength；Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yu- Hsuan ChienUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Dec 2020 (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.
According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health.
Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.
Detailed description
Purpose:This study aim is effectiveness of 12 weeks quantitative weight-bearing progressive exercise training in patients with type 2 diabetes mellitus(T2DM) with pre-sarcopenia promotion muscle strength and blood sugar control.
Hypothesis:After 12 weeks of quantitative sandbag training , the experimental group can have a significant increase in the muscle mass of the upper and lower limbs、grip strength、5-time chair stand test、Lipid profile、glycemic control(HbA1c) and quality of life.
Methods:This study will be a randomized controlled trial. Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Conditions:The effectiveness of 12 weeks quantitative weight-bearing can improvement of Glycemic control and limb muscle strength.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day.control group keep normal lives
| Arm | Type | Receives |
|---|---|---|
| Quantitative Weight-bearing | Experimental | Behavioral: Quantitative weight -bearing and report exercise sign data every weeklyExperimental wearing 0.5 kg quantitative sandbag 12~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment |
| Control group | Placebo comparator | Behavioral: Quantitative weight -bearing and report exercise sign data every weeklyThey are keep their normal live style |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 50 ~80 years
- T2DM
- Physician and check Calf circumference (M: <34 cm, F: <33 cm)、handgrip strength (M: <28 kg, F: <18 kg)
Key exclusion criteria (7 listed)
- Inability to perform any self -activity
- DM with lower limb neuropathy, r
- DM with Retinopathy
- Stroke
- Foot opening wound
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 |
|---|---|---|
| Quantitative weight -bearing and report exercise sign data every weeklyAlso: Self-managekeep their normal live style | Behavioural | Control group, Quantitative Weight-bearing |
Primary outcome
HbA1c level
Time frame: up to 12 week of invention
follow blood glucose control
muscle strength
Time frame: up to 12 weeks of intervention
follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength
muscle mass
Time frame: up to 12 weeks of invention
Use BIA(Bioelectrical impedance analysis)follow muscle mass,
5-time chair stand test
Time frame: up to 12 weeks of invention
follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability
1 secondary outcome
WHOQOL-BREF World Health Organization Quality of Life Taiwan version
Time frame: up to 12 week of invention
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 11 Mar 2022.
- Individual participant dataSharing planned: No. Currently in the submission stage, and then share with other researchers after publication
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-Jen Tsai study director
Kaohsiung Chang Gung Medication Hosipital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative weight -bearing and report exercise sign data every weekly in people with Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength, run by Yu- Hsuan Chien 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 3 inclusion and 7 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 11 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. Some participants in this study may receive a placebo. 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?
HbA1c level (time frame: up to 12 week of invention). 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 11 Mar 2022.