- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955676
The Effects of Moderate Intensity Cycle Ergometer vs. Treadmill Training on Physiological Resilience in Older Adults (MICeT)
The Effects of Moderate Intensity, Time-matched Cycle Ergometer vs. Treadmill Exercise Training on Parameters Associated With Physiological Resilience in Older Adults: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physiological resilience refers to the capacity to retain or regain physical function in the presence of diseases or age-related impairments. Poor resilience may increase vulnerability to stress, which could lead to negative functional and clinical consequences like a prolonged course of illness/hospitalization, reduced physical activity, an elevated risk of frailty, and even mortality. Physiological resilience is particularly crucial because it declines, and the likelihood of many stresses rises with age. Therefore, it is important to promote older populations' physiological resilience reserves and resources (increase their readiness levels against potential future stressors that are more likely to be seen when an individual gets older). Since risk of having stressors increases with advanced age, there is a relationship between aging and reduced readiness to stressors (low physiological resilience).
The scientific data establishing the beneficial effects of exercise is undeniable, and the advantages of exercise considerably outweigh the hazards in most adults. Although the existing evidence supports that exercise interventions are a potent tool to foster resilience in older adults, there is still a need of future studies regarding this information. Aerobic exercise (AE), one of the most recommended exercise types by the literature, has also been stated as a beneficial tool to promote physiological resilience at all stages of life through increased growth factor expression and neuroplasticity, which lower the destructive effects of chronic stress. Also, aerobic fitness has been shown to be one of the best predictors of resilience. Government guidelines recommend performing moderate-intensity AE 150 minutes per week. However, the literature does not elaborate on the details of AE interventions on physiological resilience and there is a lack of information on which AE modality is better for this purpose. Although the literature supports the idea of AE being a beneficial tool to improve health and physical fitness goals as well as resilience, it can clearly be seen that there is a need for future research regarding both the comparison of AE modalities in older adults and the effects of AE intervention to promote physiological resilience. Thus, this study will be the first to compare the effects of moderate intensity time-matched AE modalities (cycle ergometer versus treadmill training versus control group) on the parameters associated with physiological resilience (muscle mass/strength, cognition, dexterity, functional ability, cardiorespiratory fitness, and neuromuscular function) in older adults. The intervention period will last 5 weeks, 3 days a week, with 40-minute sessions. The research question will be 'Which AE modality is better in improving determinants of physiological resilience?'. This work will allow us to understand the relationship between AE and physiological resilience in a more detailed way and to prescribe better exercise prescriptions in the future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bethan E Phillips, Professor
- Phone Number: 01332 724676
- Email: beth.phillips@nottingham.ac.uk
Study Contact Backup
- Name: Jemima Collins, Assoc. Prof.
- Email: jemima.collins.old@nottingham.ac.uk
Study Locations
-
-
Derbyshire
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Derby, Derbyshire, United Kingdom, DE22 3DT
- Recruiting
- The University of Nottingham/Medical School
-
Contact:
- Bethan E Phillips, Professor
- Phone Number: 01332 724676
- Email: beth.phillips@nottingham.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study
- Participants who are able to perform exercises safely and freely
- Participants who are 60-80 years old
Exclusion Criteria:
- Cardiopulmonary diseases except for well-controlled hypertension and asthma
- Severe cognitive impairment
- Joint disorders avoiding exercise participation
- A recent heart attack, unstable angina, or severe heart failure
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
- Participants who are currently engaging in more than 150 min of moderate-intensity exercise per week or 75 min of vigorous-intensity exercise per week (WHO physical activity recommendations)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: treadmill exercise
All participants should visit the research unit and attend the sessions 3 times a week for 5 weeks.
Participants in this group will conduct moderate-intensity (64-76% of Heart rate maximum) treadmill training for 40 minutes each session.
There is a 5-min warm-up before the intervention and a 5-min cool-down period after the intervention.
|
Intervention consists of exercises only.
Participants in this group will walk on a treadmill.
The heart rates of the participants will be monitored with a heart rate monitor while exercising in order to maintain moderate-intensity.
|
|
Experimental: cycle ergometer exercise
All participants should visit the research unit and attend the sessions 3 times a week for 5 weeks.
Participants in this group will conduct moderate-intensity (64-76% of Heart rate maximum) cycle ergometer training for 40 minutes each session.
There is a 5-min warm-up before the intervention and a 5-min cool-down period after the intervention.
|
Intervention consists of exercises only.
Participants in this group will cycle on an ergometer.
The heart rates of the participants will be monitored with a heart rate monitor while exercising in order to maintain moderate-intensity.
|
|
No Intervention: control group
The control group will receive 'no intervention'.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in vastus lateralis mass
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Bioelectrical impedance analysis (BIA) and ultrasound will be used for this.
Muscle thickness, fascicle length, and pennation angle will be measured on ultrasound.
BIA is simple to use, places a minimal burden on individuals, uses lightweight and inexpensive equipment, and, most significantly, provides no radiation risk compared to many other methods.
It is also found feasible and reliable for the measurement of muscle mass for adults in clinical settings.
Ultrasonography is also a technology that is portable, safe, and clearly distinguishes between muscle and subcutaneous fat tissues as well as a valid and novel tool for muscle mass assessment.
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at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The changes of muscle strength with maximum voluntary contraction of knee extension
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Maximum voluntary contraction is a standardized technique for assessing muscle strength in healthy older adults.
Knee extension strength will be measured with an isometric dynamometer.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The change in cardiorespiratory fitness (CRF) capacity via the Ekblom-bak (EB) test
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
The EB-test consists of exercise at one standardized, low work rate followed by a higher, individually set work rate.
Both work rates are performed for 4 minutes at a cadence of 60rpm on a cycle ergometer.
The individual higher work rate is chosen by the researcher according to the participants' gender, age, and training background.
The higher work rate aims to reach the Borg rate of perceived exertion (RPE) 12-16.
Heart rate is measured during the last minute of each work rate (at 3:15, 3:30, 3:45, and 4:00).
Then, VO2max is estimated with a formula.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The difference in neuromuscular function via force accuracy task
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Force accuracy is an important parameter since most daily activities are conducted at submaximal levels, where force fluctuation can be observed and reduce the ability to create an intended movement.
Force accuracy will be measured on OTBiolab+ application.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The changes in functional ability via the Timed Up and Go test (TUG)
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
The TUG is a tool for assessing lower limb functional ability and its use has been recommended by the literature.
The time required to finish the test is commonly utilised as the primary outcome of the evaluation.
This test has previously been used in several studies to assess functional ability.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The difference between upper limb dexterity time before and after the intervention via 9-hole peg task
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
The 9-hole peg test has been shown to be a valid and reliable tool to measure upper extremity dexterity in various groups including healthy older adults.
The number of seconds it takes for the participant to complete the test is used for scoring.
A shorter completion time is a better value.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The changes in cognitive function via Mini-ACE
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
The Mini-ACE is a brief cognitive screening test that evaluates four main cognitive areas (orientation, memory, language and visuospatial function).
Higher value on this scale means better cognition.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The changes of muscle strength with handgrip strength
Time Frame: at Baseline (pre-assessment) and at the week 5 (post-assessment)
|
Isometric hand grip strength is closely correlated with the strength of the muscles in the lower extremities, and the torque of the knee, and poor mobility is clinically indicated by low handgrip strength.
Higher values mean better results.
|
at Baseline (pre-assessment) and at the week 5 (post-assessment)
|
|
The change in cardiorespiratory fitness (CRF) capacity via 6-minute walking test (6MWT)
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
In the 6MWT, participants walk as much as they can for six minutes along a continuous, interior track that is 30 metres long and has a hard surface.
It is a simple, cost-effective, and validated tool in several populations, and it has been frequently used to measure CRF as a field test.
The distance covered on this test is reported.
A higher distance covered means a better result.
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at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The difference in neuromuscular function via balance time in The Short Physical Performance Battery (SPPB) on motion platform
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Balance will be measured on FootScan (centre of pressure, distance travelled, ellipse area).
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
|
The changes in functional ability via Short Physical Performance Battery Test
Time Frame: at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Short Physical Performance Battery test includes the chair rise, balance, walk and gait speed assessments for functional mobility.
An overall score is determined on a scale from 0 to 12, with lower scores representing a more severe level of disability and higher scores representing more functionally normal levels.
|
at baseline (pre-intervention) and at the week 5 (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mehmet C Yildirim, PhD, The University of Nottingham
Publications and helpful links
General Publications
- Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Mijnarends DM, Meijers JM, Halfens RJ, ter Borg S, Luiking YC, Verlaan S, Schoberer D, Cruz Jentoft AJ, van Loon LJ, Schols JM. Validity and reliability of tools to measure muscle mass, strength, and physical performance in community-dwelling older people: a systematic review. J Am Med Dir Assoc. 2013 Mar;14(3):170-8. doi: 10.1016/j.jamda.2012.10.009. Epub 2012 Dec 29.
- Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
- Whitson HE, Duan-Porter W, Schmader KE, Morey MC, Cohen HJ, Colon-Emeric CS. Physical Resilience in Older Adults: Systematic Review and Development of an Emerging Construct. J Gerontol A Biol Sci Med Sci. 2016 Apr;71(4):489-95. doi: 10.1093/gerona/glv202. Epub 2015 Dec 29.
- Hadley EC, Kuchel GA, Newman AB; Workshop Speakers and Participants. Report: NIA Workshop on Measures of Physiologic Resiliencies in Human Aging. J Gerontol A Biol Sci Med Sci. 2017 Jul 1;72(7):980-990. doi: 10.1093/gerona/glx015. Erratum In: J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):995. doi: 10.1093/gerona/glx172.
- Cosco TD, Howse K, Brayne C. Healthy ageing, resilience and wellbeing. Epidemiol Psychiatr Sci. 2017 Dec;26(6):579-583. doi: 10.1017/S2045796017000324. Epub 2017 Jul 6.
- Sampedro-Piquero P, Moreno-Fernandez RD. Building Resilience with Aerobic Exercise: Role of FKBP5. Curr Neuropharmacol. 2021;19(8):1156-1160. doi: 10.2174/1570159X19666210408124937.
- Arida RM, Teixeira-Machado L. The Contribution of Physical Exercise to Brain Resilience. Front Behav Neurosci. 2021 Jan 20;14:626769. doi: 10.3389/fnbeh.2020.626769. eCollection 2020.
- Lee SY, Ahn S, Kim YJ, Ji MJ, Kim KM, Choi SH, Jang HC, Lim S. Comparison between Dual-Energy X-ray Absorptiometry and Bioelectrical Impedance Analyses for Accuracy in Measuring Whole Body Muscle Mass and Appendicular Skeletal Muscle Mass. Nutrients. 2018 Jun 7;10(6):738. doi: 10.3390/nu10060738.
- Scott JM, Martin DS, Ploutz-Snyder R, Matz T, Caine T, Downs M, Hackney K, Buxton R, Ryder JW, Ploutz-Snyder L. Panoramic ultrasound: a novel and valid tool for monitoring change in muscle mass. J Cachexia Sarcopenia Muscle. 2017 Jun;8(3):475-481. doi: 10.1002/jcsm.12172. Epub 2017 Jan 3.
- Meldrum D, Cahalane E, Conroy R, Fitzgerald D, Hardiman O. Maximum voluntary isometric contraction: reference values and clinical application. Amyotroph Lateral Scler. 2007 Feb;8(1):47-55. doi: 10.1080/17482960601012491. Erratum In: Amyotroph Lateral Scler. 2008;9(1):63.
- Dourado VZ, Nishiaka RK, Simoes MSMP, Lauria VT, Tanni SE, Godoy I, Gagliardi ART, Romiti M, Arantes RL. Classification of cardiorespiratory fitness using the six-minute walk test in adults: Comparison with cardiopulmonary exercise testing. Pulmonology. 2021 Nov-Dec;27(6):500-508. doi: 10.1016/j.pulmoe.2021.03.006. Epub 2021 May 4.
- Santana MG, de Lira CA, Passos GS, Santos CA, Silva AH, Yoshida CH, Tufik S, de Mello MT. Is the six-minute walk test appropriate for detecting changes in cardiorespiratory fitness in healthy elderly men? J Sci Med Sport. 2012 May;15(3):259-65. doi: 10.1016/j.jsams.2011.11.249. Epub 2011 Dec 11.
- Singh NB, Arampatzis A, Duda G, Heller MO, Taylor WR. Effect of fatigue on force fluctuations in knee extensors in young adults. Philos Trans A Math Phys Eng Sci. 2010 Jun 13;368(1920):2783-98. doi: 10.1098/rsta.2010.0091.
- Gojanovic M, Holloway-Kew KL, Hyde NK, Mohebbi M, Shivappa N, Hebert JR, O'Neil A, Pasco JA. The Dietary Inflammatory Index Is Associated with Low Muscle Mass and Low Muscle Function in Older Australians. Nutrients. 2021 Apr 1;13(4):1166. doi: 10.3390/nu13041166.
- Przkora R, Kinsky MP, Fisher SR, Babl C, Heyde CE, Vasilopoulos T, Kaye AD, Volpi E. Functional Improvements Utilizing the Short Physical Performance Battery (SPPB) in the Elderly after Epidural Steroid Injections. Curr Pain Headache Rep. 2019 Feb 22;23(2):14. doi: 10.1007/s11916-019-0748-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMHS 367-0923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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