SarcopeniaF-POWNCT02530723
Functional Changes and Power Training in Older Women.
A study testing power training in people with Sarcopenia and Muscle Weakness, run by University of Toronto at 1 site in Canada.
Trial summary
Extending quality of life and attenuating functional decline is paramount in older adults. This study investigates the effects of low-intensity power-training in older women and its effects on functional outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Weakness
- What is being tested?
- power training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 16 Jul 2018
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- females, 65 years of age
- agree to the study protocol
- give informed-consent to the proposed research study
Who cannot join
- existing acute illness/disease (last six months)
- diagnosed with myopathies
- currently prescribed cardiovascular medications or drugs that may affect muscle mass and/or their response to exercise (thyroid medications, sedatives, beta blockers, some statins)
- are diabetic
- have uncontrolled hypertension
- have been advised against participating in exercise by their doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low-intensity Power Training on Strength, Power, and Functional Outcomes in Older, Community-dwelling Women.
Extending quality of life and attenuating functional decline is paramount in older adults. This study investigates the effects of low-intensity power-training in older women and its effects on functional outcomes.
Read the detailed description
Resistance training has gained popularity in aging interventions since it is effective in countering the loss of muscle mass and strength with senescence. Traditionally, strength training (ST) protocols for the elderly have involved relatively heavy loads (70-80% of maximum force) with the focus being on increasing strength. There is some evidence of increased function after strength training albeit with inconsistent reports in the literature. More recently, several studies have designed resistance training programs that aim to increase power rather than strength, since findings indicate that measures of power are better predictors of physical function than measures of strength. In other words, improving power may be more beneficial to the elderly who are susceptible to functional limitations, mobility disability, and dependency. Since it is difficult to produce a great deal of power with increasing intensities, and lifting heavy loads may not be relevant to everyday functioning in the elderly, studies have investigated training for improvements in power rather than the traditional improvements in strength.
The effects of power training (PT) versus ST on functional outcomes in older adults have varied, with some studies showing enhanced improvements in function, and others showing no difference in function compared to regular ST or compared to other interventions such as walking. Discrepancies might be the result of the variety of functional tests used, mode of training, variable frequency of sessions per week, differences in study length, and adults of varying functional status. It has been suggested that perhaps the standard 3-sessions-per-week frequency may not be optimal for the elderly. A previous investigation demonstrated that the effects from PT at 40% of the 1-repetition maximum (1RM: the highest amount that can be lifted once) in older adults was comparable to the effects from ST at 80% 1RM with improvements being similar between the two modes despite the lower daily ratings of perceived exertion (RPE) reported with PT (PT: RPE for leg press (12.2) and knee extension (14.6) vs ST: RPE for leg press (15.1) and knee extension (17)). Therefore, an 'easier' exercise training experience did not result in sacrifices in gains of strength and power. In theory, these factors (lighter loads, lower perceived exertions, similar strength and power gains) could affect adherence to exercise during and after a research-related exercise intervention has been completed and thus are important considerations in the design of a training program.
The purpose of this research is to investigate the effects of low-intensity (40% 1RM) PT on functional outcomes in older women.
- Conditions
- Sarcopenia, Muscle Weakness
- Being tested
- power training
- Keywords
- power training, high-speed training, high-velocity training, function, older adults, older women
- Medical subject headings
- Sarcopenia, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
power trainingOther
Also called resistance training, high-speed training, high-velocity training
Resistance training machines with CAM devices will be used for training.
| Study group | Role | What they receive |
|---|---|---|
| Once a week | Experimental | Group 1 will be invited to perform resistance training exercise 1 day/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. Receives: Other: power training |
| Twice a week | Experimental | Group 2 will be invited to perform resistance training exercise 2 days/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. Receives: Other: power training |
| Thrice a week | Experimental | Group 3 will be invited to perform resistance training exercise 3 days/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. Receives: Other: power training |
| wait-control | No intervention | Participants in this group will serve as controls prior to participating in power training in 1 of the above treatment groups. The control period will last as long as the exercise period, or 3 months. Controls will participate in the same testing time points as the exercisers (baseline, midpoint, and post-intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stair-climb power
The time needed to ascend a flight of stairs, converted to power (using body-weight and stair height)
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (3)
Change in 400-meter walk test
The time needed to walk 400 meters (back and forth along a 20 meter course)
Measured: baseline, 6 weeks, 12 weeks
Change in Short Physical Performance Battery
A short test of balance, walking, and chair stand ability
Measured: baseline, 6 weeks, 12 weeks
Change in 30-second chair stand test
The number of chair stands possible in 30 seconds
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Factorial
- Model description
- With 3 groups and a wait-control group, our general design will include 4 (group) x 2 (baseline and post-study) and 4 (group) x 3 (baseline, midpoint, and post-study) analyses. We may also conduct one-way ANOVA analyses as problems with normality in the data are apparent.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantina Katsoulis, University of Toronto
- Investigators
- Catherine E Amara, Ph.D, Study director, University of Toronto; Faculty of Kinesiology and Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530723
- Sponsor's protocol ID
- 27773
- Acronym
- F-POW
- Status last verified
- Nov 2020
- First submitted
- 17 Aug 2015
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiatarone MA, O'Neill EF, Ryan ND, Clements KM, Solares GR, Nelson ME, Roberts SB, Kehayias JJ, Lipsitz LA, Evans WJ. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med. 1994 Jun 23;330(25):1769-75. doi: 10.1056/NEJM199406233302501.
PubMed 8190152Hartman MJ, Fields DA, Byrne NM, Hunter GR. Resistance training improves metabolic economy during functional tasks in older adults. J Strength Cond Res. 2007 Feb;21(1):91-5. doi: 10.1519/00124278-200702000-00017.
PubMed 17313273Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
PubMed 19910811Pojednic RM, Clark DJ, Patten C, Reid K, Phillips EM, Fielding RA. The specific contributions of force and velocity to muscle power in older adults. Exp Gerontol. 2012 Aug;47(8):608-13. doi: 10.1016/j.exger.2012.05.010. Epub 2012 May 22.
PubMed 22626972Sayers SP, Guralnik JM, Thombs LA, Fielding RA. Effect of leg muscle contraction velocity on functional performance in older men and women. J Am Geriatr Soc. 2005 Mar;53(3):467-71. doi: 10.1111/j.1532-5415.2005.53166.x.
PubMed 15743291Miszko TA, Cress ME, Slade JM, Covey CJ, Agrawal SK, Doerr CE. Effect of strength and power training on physical function in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):171-5. doi: 10.1093/gerona/58.2.m171.
PubMed 12586856Sayers SP, Gibson K. Effects of high-speed power training on muscle performance and braking speed in older adults. J Aging Res. 2012;2012:426278. doi: 10.1155/2012/426278. Epub 2012 Feb 28.
PubMed 22500229Henwood TR, Riek S, Taaffe DR. Strength versus muscle power-specific resistance training in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):83-91. doi: 10.1093/gerona/63.1.83.
PubMed 18245765Drey M, Zech A, Freiberger E, Bertsch T, Uter W, Sieber CC, Pfeifer K, Bauer JM. Effects of strength training versus power training on physical performance in prefrail community-dwelling older adults. Gerontology. 2012;58(3):197-204. doi: 10.1159/000332207. Epub 2011 Nov 3.
PubMed 22056537Earles DR, Judge JO, Gunnarsson OT. Velocity training induces power-specific adaptations in highly functioning older adults. Arch Phys Med Rehabil. 2001 Jul;82(7):872-8. doi: 10.1053/apmr.2001.23838.
PubMed 11441371Bamman MM, Hill VJ, Adams GR, Haddad F, Wetzstein CJ, Gower BA, Ahmed A, Hunter GR. Gender differences in resistance-training-induced myofiber hypertrophy among older adults. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):108-16. doi: 10.1093/gerona/58.2.b108.
PubMed 12586847Hunter GR, Wetzstein CJ, McLafferty CL Jr, Zuckerman PA, Landers KA, Bamman MM. High-resistance versus variable-resistance training in older adults. Med Sci Sports Exerc. 2001 Oct;33(10):1759-64. doi: 10.1097/00005768-200110000-00022.
PubMed 11581563Katsoulis K, Amara CE. The Effects of Power Training Frequency on Muscle Power and Functional Performance in Older Women: A Randomized Controlled Trial. J Strength Cond Res. 2023 Nov 1;37(11):2289-2297. doi: 10.1519/JSC.0000000000004527. Epub 2023 Jun 19.
PubMed 37335760
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low-intensity Power Training on Strength, Power, and Functional Outcomes in Older, Community-dwelling Women.
- ClinicalTrials.gov ID
- NCT02530723
- Acronym / sponsor ID
- F-POW / 27773
- Conditions
- Sarcopenia, Muscle Weakness
- Keywords
- power training, high-speed training, high-velocity training, function, older adults, older women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 21 Aug 2015 (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.
Extending quality of life and attenuating functional decline is paramount in older adults. This study investigates the effects of low-intensity power-training in older women and its effects on functional outcomes.
Detailed description
Resistance training has gained popularity in aging interventions since it is effective in countering the loss of muscle mass and strength with senescence. Traditionally, strength training (ST) protocols for the elderly have involved relatively heavy loads (70-80% of maximum force) with the focus being on increasing strength. There is some evidence of increased function after strength training albeit with inconsistent reports in the literature. More recently, several studies have designed resistance training programs that aim to increase power rather than strength, since findings indicate that measures of power are better predictors of physical function than measures of strength. In other words, improving power may be more beneficial to the elderly who are susceptible to functional limitations, mobility disability, and dependency. Since it is difficult to produce a great deal of power with increasing intensities, and lifting heavy loads may not be relevant to everyday functioning in the elderly, studies have investigated training for improvements in power rather than the traditional improvements in strength.
The effects of power training (PT) versus ST on functional outcomes in older adults have varied, with some studies showing enhanced improvements in function, and others showing no difference in function compared to regular ST or compared to other interventions such as walking. Discrepancies might be the result of the variety of functional tests used, mode of training, variable frequency of sessions per week, differences in study length, and adults of varying functional status. It has been suggested that perhaps the standard 3-sessions-per-week frequency may not be optimal for the elderly. A previous investigation demonstrated that the effects from PT at 40% of the 1-repetition maximum (1RM: the highest amount that can be lifted once) in older adults was comparable to the effects from ST at 80% 1RM with improvements being similar between the two modes despite the lower daily ratings of perceived exertion (RPE) reported with PT (PT: RPE for leg press (12.2) and knee extension (14.6) vs ST: RPE for leg press (15.1) and knee extension (17)). Therefore, an 'easier' exercise training experience did not result in sacrifices in gains of strength and power. In theory, these factors (lighter loads, lower perceived exertions, similar strength and power gains) could affect adherence to exercise during and after a research-related exercise intervention has been completed and thus are important considerations in the design of a training program.
The purpose of this research is to investigate the effects of low-intensity (40% 1RM) PT on functional outcomes in older women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- With 3 groups and a wait-control group, our general design will include 4 (group) x 2 (baseline and post-study) and 4 (group) x 3 (baseline, midpoint, and post-study) analyses. We may also conduct one-way ANOVA analyses as problems with normality in the data are apparent.
| Arm | Type | Receives |
|---|---|---|
| Once a week | Experimental | Other: power trainingGroup 1 will be invited to perform resistance training exercise 1 day/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. |
| Twice a week | Experimental | Other: power trainingGroup 2 will be invited to perform resistance training exercise 2 days/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. |
| Thrice a week | Experimental | Other: power trainingGroup 3 will be invited to perform resistance training exercise 3 days/week. After a 2-week familiarization phase, participants will engage in power training (40% of 1-repetition maximum) for 12 weeks. Instructions include telling participants to lift the weight concentrically 'as fast as possible', with a lowering phase (eccentric) of 2-3 seconds. Participants will perform 3 x 12-14 repetitions per exercise per session. Primarily lower body equipment will be used, including leg press, knee extension/flexion, hip extension/flexion, and calf-raises. |
| wait-control | No intervention | –Participants in this group will serve as controls prior to participating in power training in 1 of the above treatment groups. The control period will last as long as the exercise period, or 3 months. Controls will participate in the same testing time points as the exercisers (baseline, midpoint, and post-intervention). |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- females, 65 years of age
- agree to the study protocol
- give informed-consent to the proposed research study
Key exclusion criteria (6 listed)
- existing acute illness/disease (last six months)
- diagnosed with myopathies
- currently prescribed cardiovascular medications or drugs that may affect muscle mass and/or their response to exercise (thyroid medications, sedatives, beta blockers, some statins)
- are diabetic
- have uncontrolled hypertension
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 |
|---|---|---|
| power trainingAlso: resistance training, high-speed training, high-velocity trainingResistance training machines with CAM devices will be used for training. | Other | Once a week, Thrice a week, Twice a week |
Primary outcome
Change in Stair-climb power
Time frame: baseline, 6 weeks, 12 weeks
The time needed to ascend a flight of stairs, converted to power (using body-weight and stair height)
3 secondary outcomes
Change in 400-meter walk test
Time frame: baseline, 6 weeks, 12 weeks
Change in Short Physical Performance Battery
Time frame: baseline, 6 weeks, 12 weeks
Change in 30-second chair stand test
Time frame: baseline, 6 weeks, 12 weeks
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 9 Nov 2020.
- Background: PubMed 8190152Fiatarone MA, O'Neill EF, Ryan ND, Clements KM, Solares GR, Nelson ME, Roberts SB, Kehayias JJ, Lipsitz LA, Evans WJ. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med. 1994 Jun 23;330(25):1769-75. doi: 10.1056/NEJM199406233302501.
- Background: PubMed 17313273Hartman MJ, Fields DA, Byrne NM, Hunter GR. Resistance training improves metabolic economy during functional tasks in older adults. J Strength Cond Res. 2007 Feb;21(1):91-5. doi: 10.1519/00124278-200702000-00017.
- Background: PubMed 19910811Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
- Background: PubMed 22626972Pojednic RM, Clark DJ, Patten C, Reid K, Phillips EM, Fielding RA. The specific contributions of force and velocity to muscle power in older adults. Exp Gerontol. 2012 Aug;47(8):608-13. doi: 10.1016/j.exger.2012.05.010. Epub 2012 May 22.
- Background: PubMed 15743291Sayers SP, Guralnik JM, Thombs LA, Fielding RA. Effect of leg muscle contraction velocity on functional performance in older men and women. J Am Geriatr Soc. 2005 Mar;53(3):467-71. doi: 10.1111/j.1532-5415.2005.53166.x.
- Background: PubMed 12586856Miszko TA, Cress ME, Slade JM, Covey CJ, Agrawal SK, Doerr CE. Effect of strength and power training on physical function in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):171-5. doi: 10.1093/gerona/58.2.m171.
- Background: PubMed 22500229Sayers SP, Gibson K. Effects of high-speed power training on muscle performance and braking speed in older adults. J Aging Res. 2012;2012:426278. doi: 10.1155/2012/426278. Epub 2012 Feb 28.
- Background: PubMed 18245765Henwood TR, Riek S, Taaffe DR. Strength versus muscle power-specific resistance training in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):83-91. doi: 10.1093/gerona/63.1.83.
- Background: PubMed 22056537Drey M, Zech A, Freiberger E, Bertsch T, Uter W, Sieber CC, Pfeifer K, Bauer JM. Effects of strength training versus power training on physical performance in prefrail community-dwelling older adults. Gerontology. 2012;58(3):197-204. doi: 10.1159/000332207. Epub 2011 Nov 3.
- Background: PubMed 11441371Earles DR, Judge JO, Gunnarsson OT. Velocity training induces power-specific adaptations in highly functioning older adults. Arch Phys Med Rehabil. 2001 Jul;82(7):872-8. doi: 10.1053/apmr.2001.23838.
- Background: PubMed 12586847Bamman MM, Hill VJ, Adams GR, Haddad F, Wetzstein CJ, Gower BA, Ahmed A, Hunter GR. Gender differences in resistance-training-induced myofiber hypertrophy among older adults. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):108-16. doi: 10.1093/gerona/58.2.b108.
- Background: PubMed 11581563Hunter GR, Wetzstein CJ, McLafferty CL Jr, Zuckerman PA, Landers KA, Bamman MM. High-resistance versus variable-resistance training in older adults. Med Sci Sports Exerc. 2001 Oct;33(10):1759-64. doi: 10.1097/00005768-200110000-00022.
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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.
Catherine E Amara, Ph.D study director
University of Toronto; Faculty of Kinesiology and Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing power training in people with Sarcopenia and Muscle Weakness, run by University of Toronto at 1 site in Canada.
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 6 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 9 Nov 2020. 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 Canada. 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?
Change in Stair-climb power (time frame: baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530723, which also lists 13 linked publications.
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 9 Nov 2020.