Muscle WeaknessKFPS_2NCT03017365
Effects Resistance Training on Motor Control and Cognition
A study testing Stable Resistance Training, Unstable Resistance Training and Adductor/Abductor Resistance Training in people with Muscle Weakness, run by University of Kassel.
Trial summary
It is well documented that both balance and resistance training have the potential to mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Stable Resistance Training, Unstable Resistance Training and Adductor/Abductor Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 1 Apr 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- between 65 and 80 years old
- ability to walk independently without any gait aid
Who cannot join
- pathological ratings of the Clock Drawing Test (CDT),
- Mini-Mental-State-Examination (MMSE, < 24 points),
- Falls Efficacy Scale - International (FES-I, > 24 points),
- Geriatric Depression Scale (GDS, > 9 points),
- Freiburg Questionnaire of Physical Activity (FQoPA, < 1hour)
- Frontal Assessment Battery (FAB-D, < 18 points)
- any neurological, musculoskeletal or heart-related disease
About this study
Official title: Effects of Different Resistance Training Methods on Strength, Motor Control and Executive Functions in Older Adults
It is well documented that both balance and resistance training have the potential to mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. However, knowledge about the effects of specific adductor and abductor training has advantages over traditional resistance training and resistance training on unstable surfaces regarding forward propulsion. Further, the effects of different kinds of resistance training on cognition, especially embodiment is investigated.
Read the detailed description
Introduction: In the course of ageing, physical abilities decline and consequently there is an increase in risk of falling and fall incidences. Notwithstanding, the fact that causes of falls are multifactorial, losses in lower-extremity muscle strength, power and balance seem to be the most prominent intrinsic (i.e., person-related) fall risk factors in older adults. Several systematic reviews and meta-analyses highlighted the positive effects of resistance and balance training when applied as a single means, on measures of leg muscle strength, power and balance in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. Based on several investigations, it can be safely assumed that exercises conducted on unstable devices activate smaller muscles and stabilising function of bigger muscle groups. This facilitates torque and power transfer from lower to upper extremeties and is possibly responsible for similar effects as compared to stable resistance training despite lower loads. However, it is unknown if resistance training targeting adductor and abductor muscles induces similar results as compared to resistance training conducted on uneven surfaces. Moreover, physical activity has proven to affect cognitive measures positively, especially executive functions. It has yet to be determined to what extent different kinds of resistance training affect executive functions.
Methods/Design: This study is a three-arm, 10-week RCT with a 10-week no-contact follow-up. Participants were randomly allocated (1:1) to either: 1) machine-based stable resistance training (M-SRT); 2) free-weight unstable resistance training (F-URT); 3) machine-based adductor and abductor resistance training. The design and reporting of this study follows the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement for parallel group randomised trials.
Setting Participants are recruited from the communities in and around Kassel, Germany. Screening visits, measurement sessions, and the interventions are held at the Insitute of Sports and Sports Science / University of Kassel, Germany.
Recruitment strategies: Recruitment is carried out by placing 1) an advertisement in the local newspaper, 2) during a public information meeting at the local town hall and 3) word of mouth. Interested individuals contact the study coordinator by phone, where they are provided with a brief description of the study. If responses suggest study eligibility then interested individuals are invited to attend a formal in-person screening visit.
Participants:Older adults are eligible if they: 1) are aged between 65 and 80 years old 2) and able to walk independently for more than 10m. An a priori power analysis using G*Power 3.1 with an assumed type I error of .05 and a type II error of .10 (90% statistical power, correlation among groups: .5, nonsphericity correction: 1) was computed to determine an appropriate sample size to detect medium (.50 ≤ d ≤ .79) interaction effects. The calculations were based on a study assessing the effects of core strength training using unstable devices on older adults. The analysis revealed the requirement of 54 participants (18 per group) to obtain medium "time x group" interaction effects. Considering the likelihood of dropouts, at least 83 participants are going to be recruited to compensate for a possible dropout rate of ~20%.
Interventions: All intervention groups train for ten weeks, twice per week on non-consecutive days for 60 minutes each. The 10-week intervention period consistes of a one week introductory phase and three major training blocks lasting three weeks each. Training intensity is progressively and individually increased over the 10-week training program by modulating load and sets for all groups and level of instability for F-URT. After week one (50 %), four (60%), and seven (70%) the training load (weight) is increased following one repetition maximum (1-RM) testing for each major exercise. M-SRT followes a 'traditional' machine-based stable resistance training program, including squats with a smith-machine and a leg press. F-URT conducts squats and front lunges on unstable devices. M-ART uses adductor and abductor strength training machines. All three intervention groups conduct a resistance training program consisting of two main exercises, a preparation and cool-down phase. Participants perform ten minutes of low-intensity stepping on a stair-walker as a brief warm-up at the beginning of each training session, followed by the resistance exercises and walking on a treadmill as cool-down. Training under unstable surface conditions, especially with additional weight, implies a certain degree of accident risk. Due to this factor, all instability exercises are observed by instructors and secured with additional aids like boxes. Training is supervised by skilled instructors at all times. For the first two weeks the participant to instructor ratio will be 5:1, thereafter 10:1.
Outcome assessment: Outcomes are measured at baseline, 10 weeks (intervention endpoint) and 20 weeks (study endpoint). Measurement sessions are conducted on one day.
Baseline data: Baseline measurements are obtained prior to randomisation. In addition to the measurements described below, the following are also collected: demographic and general health characteristics; medical history and medications; anthropometrics and rate of falls / near falls.
- Conditions
- Muscle Weakness
- Being tested
- Stable Resistance Training, Unstable Resistance Training, Adductor/Abductor Resistance Training
- Keywords
- Motor Control, Balance
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable Resistance TrainingOther
traditional machine-based resistance training
Unstable Resistance TrainingOther
free weight resistance training using unstable devices
Adductor/Abductor Resistance TrainingOther
machine-based adductor/abductor resistance training
| Study group | Role | What they receive |
|---|---|---|
| M-SRT | Active comparator | Machine-based stable resistance training. Exercising 'traditional' machine-based resistance training. Receives: Other: Stable Resistance Training |
| F-URT | Experimental | Free weight unstable resistance training; conducted free-weight resistance training on unstable devices using dumbbells instead of exercise-machines. Receives: Other: Unstable Resistance Training |
| M-ART | Experimental | Machine-based adductor/abductor resistance training. Exercising with 'traditional' adductor/abductor machines. Receives: Other: Adductor/Abductor Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Gait Analysis
changes in variance components (Vucm, Vort, Vtot) of an uncontrolled manifold analysis; measured in rad²
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Secondary outcomes (7)
Maximal isometric leg extension strength (ILES)
change in isometric strength, measured in N
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Fall self-efficacy Questionnaire
change in anxiety score
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Proactivec Balance (timed up and go test)
change in leg strength and procative balance (seconds)
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Maximal isometric adductor and abductor strength
change in isometric strength, measured in N
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Stroop Task
change in reaction time to congruent and incongruent stimuli (ms)
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Proactivec Balance (multidirectional reach test)
change in proactive balance (cm)
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Power tests (chair rise test)
change in muscle power (seconds)
Measured: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kassel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Kibele, PhD, Study chair, University of Kassel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017365
- Sponsor's protocol ID
- KFPS17
- Acronym
- KFPS_2
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Raw results will be published. Age will be described as intervals (65-69, 70-74, 75-80) and height will be removed, thus no backtracking is possible
Publications
Eckardt N. Lower-extremity resistance training on unstable surfaces improves proxies of muscle strength, power and balance in healthy older adults: a randomised control trial. BMC Geriatr. 2016 Nov 24;16(1):191. doi: 10.1186/s12877-016-0366-3.
PubMed 27881086Granacher U, Muehlbauer T, Gruber M. A qualitative review of balance and strength performance in healthy older adults: impact for testing and training. J Aging Res. 2012;2012:708905. doi: 10.1155/2012/708905. Epub 2012 Jan 23.
PubMed 22315687Steadman J, Donaldson N, Kalra L. A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients. J Am Geriatr Soc. 2003 Jun;51(6):847-52. doi: 10.1046/j.1365-2389.2003.51268.x.
PubMed 12757574Behm DG, Muehlbauer T, Kibele A, Granacher U. Effects of Strength Training Using Unstable Surfaces on Strength, Power and Balance Performance Across the Lifespan: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1645-69. doi: 10.1007/s40279-015-0384-x.
PubMed 26359066Eckardt N, Rosenblatt NJ. Instability Resistance Training Decreases Motor Noise During Challenging Walking Tasks in Older Adults: A 10-Week Double-Blinded RCT. Front Aging Neurosci. 2019 Feb 27;11:32. doi: 10.3389/fnagi.2019.00032. eCollection 2019.
PubMed 30873017
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Resistance Training Methods on Strength, Motor Control and Executive Functions in Older Adults
- ClinicalTrials.gov ID
- NCT03017365
- Acronym / sponsor ID
- KFPS_2 / KFPS17
- Conditions
- Muscle Weakness
- Keywords
- Motor Control, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of KasselUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 11 Jan 2017 (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.
It is well documented that both balance and resistance training have the potential to mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. However, knowledge about the effects of specific adductor and abductor training has advantages over traditional resistance training and resistance training on unstable surfaces regarding forward propulsion. Further, the effects of different kinds of resistance training on cognition, especially embodiment is investigated.
Detailed description
Introduction: In the course of ageing, physical abilities decline and consequently there is an increase in risk of falling and fall incidences. Notwithstanding, the fact that causes of falls are multifactorial, losses in lower-extremity muscle strength, power and balance seem to be the most prominent intrinsic (i.e., person-related) fall risk factors in older adults. Several systematic reviews and meta-analyses highlighted the positive effects of resistance and balance training when applied as a single means, on measures of leg muscle strength, power and balance in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. Based on several investigations, it can be safely assumed that exercises conducted on unstable devices activate smaller muscles and stabilising function of bigger muscle groups. This facilitates torque and power transfer from lower to upper extremeties and is possibly responsible for similar effects as compared to stable resistance training despite lower loads. However, it is unknown if resistance training targeting adductor and abductor muscles induces similar results as compared to resistance training conducted on uneven surfaces. Moreover, physical activity has proven to affect cognitive measures positively, especially executive functions. It has yet to be determined to what extent different kinds of resistance training affect executive functions.
Methods/Design: This study is a three-arm, 10-week RCT with a 10-week no-contact follow-up. Participants were randomly allocated (1:1) to either: 1) machine-based stable resistance training (M-SRT); 2) free-weight unstable resistance training (F-URT); 3) machine-based adductor and abductor resistance training. The design and reporting of this study follows the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement for parallel group randomised trials.
Setting Participants are recruited from the communities in and around Kassel, Germany. Screening visits, measurement sessions, and the interventions are held at the Insitute of Sports and Sports Science / University of Kassel, Germany.
Recruitment strategies: Recruitment is carried out by placing 1) an advertisement in the local newspaper, 2) during a public information meeting at the local town hall and 3) word of mouth. Interested individuals contact the study coordinator by phone, where they are provided with a brief description of the study. If responses suggest study eligibility then interested individuals are invited to attend a formal in-person screening visit.
Participants:Older adults are eligible if they: 1) are aged between 65 and 80 years old 2) and able to walk independently for more than 10m. An a priori power analysis using G*Power 3.1 with an assumed type I error of .05 and a type II error of .10 (90% statistical power, correlation among groups: .5, nonsphericity correction: 1) was computed to determine an appropriate sample size to detect medium (.50 ≤ d ≤ .79) interaction effects. The calculations were based on a study assessing the effects of core strength training using unstable devices on older adults. The analysis revealed the requirement of 54 participants (18 per group) to obtain medium "time x group" interaction effects. Considering the likelihood of dropouts, at least 83 participants are going to be recruited to compensate for a possible dropout rate of ~20%.
Interventions: All intervention groups train for ten weeks, twice per week on non-consecutive days for 60 minutes each. The 10-week intervention period consistes of a one week introductory phase and three major training blocks lasting three weeks each. Training intensity is progressively and individually increased over the 10-week training program by modulating load and sets for all groups and level of instability for F-URT. After week one (50 %), four (60%), and seven (70%) the training load (weight) is increased following one repetition maximum (1-RM) testing for each major exercise. M-SRT followes a 'traditional' machine-based stable resistance training program, including squats with a smith-machine and a leg press. F-URT conducts squats and front lunges on unstable devices. M-ART uses adductor and abductor strength training machines. All three intervention groups conduct a resistance training program consisting of two main exercises, a preparation and cool-down phase. Participants perform ten minutes of low-intensity stepping on a stair-walker as a brief warm-up at the beginning of each training session, followed by the resistance exercises and walking on a treadmill as cool-down. Training under unstable surface conditions, especially with additional weight, implies a certain degree of accident risk. Due to this factor, all instability exercises are observed by instructors and secured with additional aids like boxes. Training is supervised by skilled instructors at all times. For the first two weeks the participant to instructor ratio will be 5:1, thereafter 10:1.
Outcome assessment: Outcomes are measured at baseline, 10 weeks (intervention endpoint) and 20 weeks (study endpoint). Measurement sessions are conducted on one day.
Baseline data: Baseline measurements are obtained prior to randomisation. In addition to the measurements described below, the following are also collected: demographic and general health characteristics; medical history and medications; anthropometrics and rate of falls / near falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M-SRT | Active comparator | Other: Stable Resistance TrainingMachine-based stable resistance training. Exercising 'traditional' machine-based resistance training. |
| F-URT | Experimental | Other: Unstable Resistance TrainingFree weight unstable resistance training; conducted free-weight resistance training on unstable devices using dumbbells instead of exercise-machines. |
| M-ART | Experimental | Other: Adductor/Abductor Resistance TrainingMachine-based adductor/abductor resistance training. Exercising with 'traditional' adductor/abductor machines. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- between 65 and 80 years old
- ability to walk independently without any gait aid
Key exclusion criteria (7 listed)
- pathological ratings of the Clock Drawing Test (CDT),
- Mini-Mental-State-Examination (MMSE, < 24 points),
- Falls Efficacy Scale - International (FES-I, > 24 points),
- Geriatric Depression Scale (GDS, > 9 points),
- Freiburg Questionnaire of Physical Activity (FQoPA, < 1hour)
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 |
|---|---|---|
| Stable Resistance Trainingtraditional machine-based resistance training | Other | M-SRT |
| Unstable Resistance Trainingfree weight resistance training using unstable devices | Other | F-URT |
| Adductor/Abductor Resistance Trainingmachine-based adductor/abductor resistance training | Other | M-ART |
Primary outcome
Clinical Gait Analysis
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
changes in variance components (Vucm, Vort, Vtot) of an uncontrolled manifold analysis; measured in rad²
7 secondary outcomes
Maximal isometric leg extension strength (ILES)
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Fall self-efficacy Questionnaire
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Proactivec Balance (timed up and go test)
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Maximal isometric adductor and abductor strength
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Stroop Task
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Proactivec Balance (multidirectional reach test)
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
Power tests (chair rise test)
Time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
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 7 Feb 2018.
- Background: PubMed 27881086Eckardt N. Lower-extremity resistance training on unstable surfaces improves proxies of muscle strength, power and balance in healthy older adults: a randomised control trial. BMC Geriatr. 2016 Nov 24;16(1):191. doi: 10.1186/s12877-016-0366-3.
- Background: PubMed 22315687Granacher U, Muehlbauer T, Gruber M. A qualitative review of balance and strength performance in healthy older adults: impact for testing and training. J Aging Res. 2012;2012:708905. doi: 10.1155/2012/708905. Epub 2012 Jan 23.
- Background: PubMed 12757574Steadman J, Donaldson N, Kalra L. A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients. J Am Geriatr Soc. 2003 Jun;51(6):847-52. doi: 10.1046/j.1365-2389.2003.51268.x.
- Background: PubMed 26359066Behm DG, Muehlbauer T, Kibele A, Granacher U. Effects of Strength Training Using Unstable Surfaces on Strength, Power and Balance Performance Across the Lifespan: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1645-69. doi: 10.1007/s40279-015-0384-x.
- Derived from this study: PubMed 30873017Eckardt N, Rosenblatt NJ. Instability Resistance Training Decreases Motor Noise During Challenging Walking Tasks in Older Adults: A 10-Week Double-Blinded RCT. Front Aging Neurosci. 2019 Feb 27;11:32. doi: 10.3389/fnagi.2019.00032. eCollection 2019.
- Individual participant dataSharing planned: Yes. Raw results will be published. Age will be described as intervals (65-69, 70-74, 75-80) and height will be removed, thus no backtracking is possible
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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.
Armin Kibele, PhD study chair
University of Kassel
Questions about this trial
What is this clinical trial studying?
A study testing Stable Resistance Training, Unstable Resistance Training and Adductor/Abductor Resistance Training in people with Muscle Weakness, run by University of Kassel.
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 2 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Gait Analysis (time frame: Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)). 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 NCT03017365, which also lists 5 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 7 Feb 2018.