NCT06955676

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 2, 2025

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 27, 2024

Last Update Submit

April 24, 2025

Conditions

Keywords

aerobic exerciseolder adultselderlyresiliencetreadmillcycle ergometer

Outcome Measures

Primary Outcomes (11)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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).

    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.

    at baseline (pre-intervention) and at the week 5 (post-intervention)

Study Arms (3)

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.

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.

Other: cycle ergometer exercise

control group

NO INTERVENTION

The control group will receive 'no intervention'.

Interventions

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.

treadmill exercise

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.

cycle ergometer exercise

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Nottingham/Medical School

Derby, Derbyshire, DE22 3DT, United Kingdom

RECRUITING

Related Publications (16)

  • 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.

    PMID: 26718984BACKGROUND
  • 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.

    PMID: 28475732BACKGROUND
  • 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.

    PMID: 28679453BACKGROUND
  • 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.

    PMID: 33829973BACKGROUND
  • 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.

    PMID: 33584215BACKGROUND
  • 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.

    PMID: 29880741BACKGROUND
  • 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.

    PMID: 23276432BACKGROUND
  • 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.

    PMID: 28052593BACKGROUND
  • 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.

    PMID: 17364436BACKGROUND
  • 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.

    PMID: 14555665BACKGROUND
  • 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.

    PMID: 33958319BACKGROUND
  • 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.

    PMID: 22154397BACKGROUND
  • 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.

    PMID: 20439273BACKGROUND
  • 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.

    PMID: 20392703BACKGROUND
  • 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.

    PMID: 33916033BACKGROUND
  • 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.

    PMID: 30796532BACKGROUND

Study Officials

  • Mehmet C Yildirim, PhD

    The University of Nottingham

    STUDY DIRECTOR

Central Study Contacts

Bethan E Phillips, Professor

CONTACT

Jemima Collins, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: moderate-intensity treadmill training Group 2: moderate-intensity cycle ergometer training Group 3: control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Physiology

Study Record Dates

First Submitted

September 27, 2024

First Posted

May 2, 2025

Study Start

June 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

May 2, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations