Older PeopleMICeTNCT06955676
The Effects of Moderate Intensity Cycle Ergometer vs. Treadmill Training on Physiological Resilience in Older Adults
A study testing treadmill exercise and cycle ergometer exercise in people with Older People, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Government guidelines suggest that we should all take part in approximately two and a half hours each week of moderate-intensity aerobic exercise. Older adults are particularly important as their overall health may decline as they get older. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older People
- What is being tested?
- treadmill exercise and cycle ergometer exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to 1 Feb 2026
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Jemima Collins, Assoc. Prof. contact
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Nottingham/Medical School
Derby, Derbyshire, DE22 3DT
Bethan E Phillips, Professor, 01332 724676, beth.phillips@nottingham.ac.uk
About this study
Official title: 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
Government guidelines suggest that we should all take part in approximately two and a half hours each week of moderate-intensity aerobic exercise. Older adults are particularly important as their overall health may decline as they get older. Therefore, exercising is important especially for older adults to improve heart and muscle health and functioning in carrying out tasks of daily living. The overall effects of aging on the body can make people less likely to withstand challenges to the body - this is termed 'resilience'. Although aerobic exercise is not super easy and requires continuity, it is not extremely difficult to get used to. However, we still do not know if some types of aerobic exercise are better for you than others at improving resilience. Therefore, this study will look at cycling vs walking to see if one is better at improving resilience in older adults who are 60-80 years old. You will be trained on either a treadmill or cycle ergometer and these exercise sessions will be done over 5 weeks, 3 days a week. Each session will last 40 minutes, start with warm-up and end with cool-down sessions. Assessments will include heart, lung, muscle, and memory and thinking measurements, all of which will be taken before and after the intervention period. This work will help us to better understand how we can improve exercise prescriptions for older adults to sustain their health and functioning in their daily life.
Read the 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.
- Conditions
- Older People
- Being tested
- treadmill exercise, cycle ergometer exercise
- Keywords
- aerobic exercise, older adults, elderly, resilience, treadmill, cycle ergometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill exerciseOther
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.
cycle ergometer exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| treadmill exercise | Experimental | 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. Receives: Other: treadmill exercise |
| cycle ergometer exercise | Experimental | 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. Receives: Other: cycle ergometer exercise |
| control group | No intervention | The control group will receive 'no intervention'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in vastus lateralis mass
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The changes of muscle strength with maximum voluntary contraction of knee extension
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The change in cardiorespiratory fitness (CRF) capacity via the Ekblom-bak (EB) test
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The difference in neuromuscular function via force accuracy task
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The changes in functional ability via the Timed Up and Go test (TUG)
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.
Measured: 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
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The changes in cognitive function via Mini-ACE
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The changes of muscle strength with handgrip strength
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.
Measured: at Baseline (pre-assessment) and at the week 5 (post-assessment)
The change in cardiorespiratory fitness (CRF) capacity via 6-minute walking test (6MWT)
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.
Measured: 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
Balance will be measured on FootScan (centre of pressure, distance travelled, ellipse area).
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
The changes in functional ability via Short Physical Performance Battery Test
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.
Measured: at baseline (pre-intervention) and at the week 5 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Jun 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Parallel groups
- Model description
- Group 1: moderate-intensity treadmill training Group 2: moderate-intensity cycle ergometer training Group 3: control
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethan Phillips, University of Nottingham
- Investigators
- Mehmet C Yildirim, PhD, Study director, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955676
- Sponsor's protocol ID
- FMHS 367-0923
- Acronym
- MICeT
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26718984Hadley 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.
PubMed 28475732Cosco 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.
PubMed 28679453Sampedro-Piquero P, Moreno-Fernandez RD. Building Resilience with Aerobic Exercise: Role of FKBP5. Curr Neuropharmacol. 2021;19(8):1156-1160. doi: 10.2174/1570159X19666210408124937.
PubMed 33829973Arida 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.
PubMed 33584215Lee 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.
PubMed 29880741Mijnarends 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.
PubMed 23276432Scott 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.
PubMed 28052593Meldrum 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.
PubMed 17364436Lauretani 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.
PubMed 14555665Dourado 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.
PubMed 33958319Santana 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.
PubMed 22154397Singh 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.
PubMed 20439273Cruz-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.
PubMed 20392703Gojanovic 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.
PubMed 33916033
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06955676
- Acronym / sponsor ID
- MICeT / FMHS 367-0923
- Conditions
- Older People
- Keywords
- aerobic exercise, older adults, elderly, resilience, treadmill, cycle ergometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 2 May 2025 (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.
Government guidelines suggest that we should all take part in approximately two and a half hours each week of moderate-intensity aerobic exercise. Older adults are particularly important as their overall health may decline as they get older. Therefore, exercising is important especially for older adults to improve heart and muscle health and functioning in carrying out tasks of daily living. The overall effects of aging on the body can make people less likely to withstand challenges to the body - this is termed 'resilience'. Although aerobic exercise is not super easy and requires continuity, it is not extremely difficult to get used to. However, we still do not know if some types of aerobic exercise are better for you than others at improving resilience. Therefore, this study will look at cycling vs walking to see if one is better at improving resilience in older adults who are 60-80 years old. You will be trained on either a treadmill or cycle ergometer and these exercise sessions will be done over 5 weeks, 3 days a week. Each session will last 40 minutes, start with warm-up and end with cool-down sessions. Assessments will include heart, lung, muscle, and memory and thinking measurements, all of which will be taken before and after the intervention period. This work will help us to better understand how we can improve exercise prescriptions for older adults to sustain their health and functioning in their daily life.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group 1: moderate-intensity treadmill training Group 2: moderate-intensity cycle ergometer training Group 3: control
| Arm | Type | Receives |
|---|---|---|
| treadmill exercise | Experimental | Other: treadmill exerciseAll 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. |
| cycle ergometer exercise | Experimental | Other: cycle ergometer exerciseAll 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. |
| control group | No intervention | –The control group will receive 'no intervention'. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| treadmill exerciseIntervention 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. | Other | treadmill exercise |
| cycle ergometer exerciseIntervention 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. | Other | cycle ergometer exercise |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 26718984Whitson 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.
- Background: PubMed 28475732Hadley 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.
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- Individual participant dataSharing planned: No
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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.
Jemima Collins, Assoc. Prof. contact
Mehmet C Yildirim, PhD study director
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill exercise and cycle ergometer exercise in people with Older People, run by University of Nottingham at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 2 May 2025. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bethan E Phillips, Professor (01332 724676, beth.phillips@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in vastus lateralis mass (time frame: at baseline (pre-intervention) and at the week 5 (post-intervention)). The study lists 11 primary outcomes in all. 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 NCT06955676, which also lists 16 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 2 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.