ExerciseNCT03282175
Effects of Elastic Resistance Training on Performance and Biochemical Parameters
A study testing Exercise and Training in people with Exercise, run by University of Primorska.
Trial summary
The aim of this study was to investigate the acute and chronic effect of elastic resistance exercise in elderly women living in a nursing home. The primary outcome was the functional performance and hand grip strength. The secondary outcomes were myokines and inflammatory markers analysis. Read more about this study
- Who is it for?
- Ages 65 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Exercise and Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 30 Jun 2016
- 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 99 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- nursing home residents
- participants did not perform any regular resistance training
Who cannot join
- immobility
- implantable cardiac peacemaker
- severe dementia
- terminal illness
About this study
Official title: Effects of Elastic Resistance Training on Physical Performance, Inflammatory Marker and Myokines in Elderly Women
The aim of this study was to investigate the acute and chronic effect of elastic resistance exercise in elderly women living in a nursing home. The primary outcome was the functional performance and hand grip strength. The secondary outcomes were myokines and inflammatory markers analysis.
Read the detailed description
Evidence regarding the relationship between RT and systemic myokine responses, as well as inflammation and physical performance in elderly is limited. Thus, this study aimed to evaluate the effect of short-term progressive elastic resistance training on muscular strength and physical performance, as well as the acute and chronic response of myokines and inflammatory markers after resistance exercise in elderly women living in a nursing home. From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home in the south of Slovenia to participate in our study.
The experimental design consisted of 1) baseline testing; 2) acute elastic resistance exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of supervised, progressive elastic resistance training program of moderate intensity; and 4) post-training testing.
The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a human premixed 4-plex kit (R\&D System Inc., Minneapolis, MN, USA), strictly following the manufacturer's instructions.
Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test was applied for statistically significant interaction. To test for significant differences between groups relating anthropometric and biochemical variables, we used a Student's t-test. All values are expressed as mean and standard deviation (SD). P values of <0.05 is considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).
- Conditions
- Exercise
- Being tested
- Exercise, Training, Control group
- Keywords
- BDNF, interleukin-15, interleukin-8, resistin, SPPB
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
TrainingOther
Each training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
Control groupOther
The control group did not receive any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participant in this group performed an acute resistance exercise protocol. The exercise protocol consisted of general warm-up of 10 min, followed by 8 exercises with 2 sets of 8 repetition and 1 min between sets. Receives: Other: Exercise |
| Training | Experimental | Participants allocated to intervention group initiated the progressive resistance training program of moderate intensity, with three weekly sessions throughout the 12-week treatment period. Receives: Other: Training |
| Control group | Active comparator | Participants allocated to control group did not receive any placebo or treatment. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance
A short battery of physical performance tests (SPPB) was used to assess baseline and post-training lower extremity function (0-12 point scale).
Measured: 1 week
Secondary outcomes (2)
Acute effect of resistance exercise
The acute effect of resistance exercise on plasma concentrations of myokines and inflammatory markers measured pre-, post- and 2h post-exercise.
Measured: 4 hours
Biochemical analysis of chronic effect of resistance training
The chronic effect of resistance training on plasma concentrations of myokines and inflammatory markers measured at baseline and post-training.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start15 Jan 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felicita Urzi, MSc, Principal investigator, University of Primorska Faculty of Mathematics, Natural Sciences and Information Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282175
- Sponsor's protocol ID
- UP-FVZ-ERT-Myokine
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Argiles JM, Lopez-Soriano FJ, Busquets S. Therapeutic potential of interleukin-15: a myokine involved in muscle wasting and adiposity. Drug Discov Today. 2009 Feb;14(3-4):208-13. doi: 10.1016/j.drudis.2008.10.010. Epub 2008 Dec 16.
PubMed 19041416Busquets S, Figueras M, Almendro V, Lopez-Soriano FJ, Argiles JM. Interleukin-15 increases glucose uptake in skeletal muscle. An antidiabetogenic effect of the cytokine. Biochim Biophys Acta. 2006 Nov;1760(11):1613-7. doi: 10.1016/j.bbagen.2006.09.001. Epub 2006 Sep 12.
PubMed 17056184Geroldi D, Minoretti P, Emanuele E. Brain-derived neurotrophic factor and the metabolic syndrome: more than just a hypothesis. Med Hypotheses. 2006;67(1):195-6. doi: 10.1016/j.mehy.2006.02.001. Epub 2006 Mar 20. No abstract available.
PubMed 16545915Martins WR, Safons MP, Bottaro M, Blasczyk JC, Diniz LR, Fonseca RM, Bonini-Rocha AC, de Oliveira RJ. Effects of short term elastic resistance training on muscle mass and strength in untrained older adults: a randomized clinical trial. BMC Geriatr. 2015 Aug 12;15:99. doi: 10.1186/s12877-015-0101-5.
PubMed 26265075Oesen S, Halper B, Hofmann M, Jandrasits W, Franzke B, Strasser EM, Graf A, Tschan H, Bachl N, Quittan M, Wagner KH, Wessner B. Effects of elastic band resistance training and nutritional supplementation on physical performance of institutionalised elderly--A randomized controlled trial. Exp Gerontol. 2015 Dec;72:99-108. doi: 10.1016/j.exger.2015.08.013. Epub 2015 Sep 2.
PubMed 26341720Prestes J, Shiguemoto G, Botero JP, Frollini A, Dias R, Leite R, Pereira G, Magosso R, Baldissera V, Cavaglieri C, Perez S. Effects of resistance training on resistin, leptin, cytokines, and muscle force in elderly post-menopausal women. J Sports Sci. 2009 Dec;27(14):1607-15. doi: 10.1080/02640410903352923.
PubMed 19967592Pereira DS, de Queiroz BZ, Miranda AS, Rocha NP, Felicio DC, Mateo EC, Favero M, Coelho FM, Jesus-Moraleida F, Gomes Pereira DA, Teixeira AL, Maximo Pereira LS. Effects of physical exercise on plasma levels of brain-derived neurotrophic factor and depressive symptoms in elderly women--a randomized clinical trial. Arch Phys Med Rehabil. 2013 Aug;94(8):1443-50. doi: 10.1016/j.apmr.2013.03.029. Epub 2013 Apr 18.
PubMed 23602881Troseid M, Lappegard KT, Claudi T, Damas JK, Morkrid L, Brendberg R, Mollnes TE. Exercise reduces plasma levels of the chemokines MCP-1 and IL-8 in subjects with the metabolic syndrome. Eur Heart J. 2004 Feb;25(4):349-55. doi: 10.1016/j.ehj.2003.12.006.
PubMed 14984925Yeo NH, Woo J, Shin KO, Park JY, Kang S. The effects of different exercise intensity on myokine and angiogenesis factors. J Sports Med Phys Fitness. 2012 Aug;52(4):448-54.
PubMed 22828466
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Resistance Training on Physical Performance, Inflammatory Marker and Myokines in Elderly Women
- ClinicalTrials.gov ID
- NCT03282175
- Acronym / sponsor ID
- UP-FVZ-ERT-Myokine
- Conditions
- Exercise
- Keywords
- BDNF, interleukin-15, interleukin-8, resistin, SPPB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 13 Sep 2017 (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.
The aim of this study was to investigate the acute and chronic effect of elastic resistance exercise in elderly women living in a nursing home. The primary outcome was the functional performance and hand grip strength. The secondary outcomes were myokines and inflammatory markers analysis.
Detailed description
Evidence regarding the relationship between RT and systemic myokine responses, as well as inflammation and physical performance in elderly is limited. Thus, this study aimed to evaluate the effect of short-term progressive elastic resistance training on muscular strength and physical performance, as well as the acute and chronic response of myokines and inflammatory markers after resistance exercise in elderly women living in a nursing home. From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home in the south of Slovenia to participate in our study.
The experimental design consisted of 1) baseline testing; 2) acute elastic resistance exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of supervised, progressive elastic resistance training program of moderate intensity; and 4) post-training testing.
The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a human premixed 4-plex kit (R\&D System Inc., Minneapolis, MN, USA), strictly following the manufacturer's instructions.
Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test was applied for statistically significant interaction. To test for significant differences between groups relating anthropometric and biochemical variables, we used a Student's t-test. All values are expressed as mean and standard deviation (SD). P values of <0.05 is considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipant in this group performed an acute resistance exercise protocol. The exercise protocol consisted of general warm-up of 10 min, followed by 8 exercises with 2 sets of 8 repetition and 1 min between sets. |
| Training | Experimental | Other: TrainingParticipants allocated to intervention group initiated the progressive resistance training program of moderate intensity, with three weekly sessions throughout the 12-week treatment period. |
| Control group | Active comparator | Other: Control groupParticipants allocated to control group did not receive any placebo or treatment. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- nursing home residents
- participants did not perform any regular resistance training
Key exclusion criteria (4 listed)
- immobility
- implantable cardiac peacemaker
- severe dementia
- terminal illness
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 |
|---|---|---|
| ExerciseExercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min. | Other | Exercise |
| TrainingEach training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min. | Other | Training |
| Control groupThe control group did not receive any treatment. | Other | Control group |
Primary outcome
Functional performance
Time frame: 1 week
A short battery of physical performance tests (SPPB) was used to assess baseline and post-training lower extremity function (0-12 point scale).
2 secondary outcomes
Acute effect of resistance exercise
Time frame: 4 hours
Biochemical analysis of chronic effect of resistance training
Time frame: 2 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 28 Sep 2017.
- Background: PubMed 19041416Argiles JM, Lopez-Soriano FJ, Busquets S. Therapeutic potential of interleukin-15: a myokine involved in muscle wasting and adiposity. Drug Discov Today. 2009 Feb;14(3-4):208-13. doi: 10.1016/j.drudis.2008.10.010. Epub 2008 Dec 16.
- Background: PubMed 17056184Busquets S, Figueras M, Almendro V, Lopez-Soriano FJ, Argiles JM. Interleukin-15 increases glucose uptake in skeletal muscle. An antidiabetogenic effect of the cytokine. Biochim Biophys Acta. 2006 Nov;1760(11):1613-7. doi: 10.1016/j.bbagen.2006.09.001. Epub 2006 Sep 12.
- Background: PubMed 16545915Geroldi D, Minoretti P, Emanuele E. Brain-derived neurotrophic factor and the metabolic syndrome: more than just a hypothesis. Med Hypotheses. 2006;67(1):195-6. doi: 10.1016/j.mehy.2006.02.001. Epub 2006 Mar 20. No abstract available.
- Background: PubMed 26265075Martins WR, Safons MP, Bottaro M, Blasczyk JC, Diniz LR, Fonseca RM, Bonini-Rocha AC, de Oliveira RJ. Effects of short term elastic resistance training on muscle mass and strength in untrained older adults: a randomized clinical trial. BMC Geriatr. 2015 Aug 12;15:99. doi: 10.1186/s12877-015-0101-5.
- Background: PubMed 26341720Oesen S, Halper B, Hofmann M, Jandrasits W, Franzke B, Strasser EM, Graf A, Tschan H, Bachl N, Quittan M, Wagner KH, Wessner B. Effects of elastic band resistance training and nutritional supplementation on physical performance of institutionalised elderly--A randomized controlled trial. Exp Gerontol. 2015 Dec;72:99-108. doi: 10.1016/j.exger.2015.08.013. Epub 2015 Sep 2.
- Background: PubMed 19967592Prestes J, Shiguemoto G, Botero JP, Frollini A, Dias R, Leite R, Pereira G, Magosso R, Baldissera V, Cavaglieri C, Perez S. Effects of resistance training on resistin, leptin, cytokines, and muscle force in elderly post-menopausal women. J Sports Sci. 2009 Dec;27(14):1607-15. doi: 10.1080/02640410903352923.
- Background: PubMed 23602881Pereira DS, de Queiroz BZ, Miranda AS, Rocha NP, Felicio DC, Mateo EC, Favero M, Coelho FM, Jesus-Moraleida F, Gomes Pereira DA, Teixeira AL, Maximo Pereira LS. Effects of physical exercise on plasma levels of brain-derived neurotrophic factor and depressive symptoms in elderly women--a randomized clinical trial. Arch Phys Med Rehabil. 2013 Aug;94(8):1443-50. doi: 10.1016/j.apmr.2013.03.029. Epub 2013 Apr 18.
- Background: PubMed 14984925Troseid M, Lappegard KT, Claudi T, Damas JK, Morkrid L, Brendberg R, Mollnes TE. Exercise reduces plasma levels of the chemokines MCP-1 and IL-8 in subjects with the metabolic syndrome. Eur Heart J. 2004 Feb;25(4):349-55. doi: 10.1016/j.ehj.2003.12.006.
- Background: PubMed 22828466Yeo NH, Woo J, Shin KO, Park JY, Kang S. The effects of different exercise intensity on myokine and angiogenesis factors. J Sports Med Phys Fitness. 2012 Aug;52(4):448-54.
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
Felicita Urzi, MSc principal investigator
University of Primorska Faculty of Mathematics, Natural Sciences and Information Technologies
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Training in people with Exercise, run by University of Primorska.
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 4 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 28 Sep 2017. 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?
Functional performance (time frame: 1 week). 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 NCT03282175, which also lists 9 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 28 Sep 2017.