NCT07369440

Brief Summary

Aging leads to substantial alterations in the nervous and skeletal muscle systems that ultimately lead to a reduction in "neural drive" and motor performance. While maximal strength starts declining as early as 50 years of age, aging brings even greater reductions in rate of force development and muscle power, that has been shown to be a stronger predictor of functional independence and balance impairments. Falls are a major health concern as one third of adults over 65 years loses balance and falls every year, and based on a published report, the estimated health care costs associated with falls in the European Union is €25 billion. The ability to recover balance declines with aging, where older individuals often recover balance with a greater number of balance recovery steps and non-optimal stepping strategies. In addition, older adults have more difficulty recovering balance in the medio-lateral direction. The hip abductors are fundamental in controlling the motion of the body centre of mass in this direction during weight transfers of standing, stepping, and walking. Furthermore, these muscles appear to be more susceptible to age-related composition and performance declines than other muscles of the lower limbs, especially in individuals at a higher risk for falls. Unfortunately, common balance interventions, such as, functional balance training, Tai-Chi, or dance, have a very limited capacity to reduce the risk of falls in older adults. Interestingly, resistance training is relatively better than the mentioned interventions at reducing this problem. This may come about through mitigating the agerelated neuromuscular performance deficits. However, traditional resistance training lacks the emphasis in high velocity movements required for adequate fall prevention protective stepping strategies. Muscle power training is a safe and effective alternative to traditional resistance training. By emphasizing in maximum speed of execution, its results are often better than with traditional resistance training, especially in functional outcomes, with the potential to enhance balance recovery. However, there is little and inconsistent evidence on the optimal exercise parameters (such as velocity) for prevention of falls. Community-based multi-component exercise programs are often used to promote health and functional benefits in the older adult population. These programs not only have a positive impact in a larger number of communitydwelling individuals, but can also lead to significant improvements. Nonetheless, these programs limited in reducing the risk for falls. Considering the robust effects of muscle power training in the older population, it is conceivable that a multi-component community-based exercise intervention, that focuses on developing muscle power and reduce fall risk, can improve the older individuals' ability to recover balance and consequently, bring greater benefits to the older adult community. However, there is no information on the feasibility of conducting an exercise program to develop muscle power and reduce fall risk in a community-based setting. Furthermore, it is generally unknown if such an exercise intervention can improve function, balance, and reduce the occurrence of falls in older adults especially, among those that have fallen in the past- which are the most relevant target population for both clinical studies and practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Sep 2024

Typical duration for not_applicable

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 Progress56%
Sep 2024Aug 2027

Study Start

First participant enrolled

September 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

September 17, 2024

Last Update Submit

January 18, 2026

Conditions

Keywords

Older adultsFallersPower TrainingFunctional mobilityBalance

Outcome Measures

Primary Outcomes (8)

  • Neuromuscular Assessments

    Handgrip strength was assessed through sustained isometric maximal voluntary contractions (IMVC) using a digital handgrip dynamometer (Gripwisetech, PT). Participants were seated with the shoulder adducted, elbow flexed at 90°, forearm in neutral position and wrist in slight extension. Three maximal isometric contractions of 15 seconds were performed with the dominant hand, with 2 minutes of rest between trials. Maximal force was defined as the highest peak force achieved during the contraction. Rate of force development (RFD) was calculated as the slope of the force-time curve during the initial phase of contraction (0-200 ms). The best trial was used for analysis.

    12 weeks

  • Neuromuscular Assessments

    Maximal isometric strength of the knee extensors, hip extensors, and hip abductors was assessed using isometric maximal voluntary contractions (IMVC) with a computer-controlled dynamometer (DESMOTEC, IT). All contractions were performed at the joint neutral position (0°) defined for each test. Participants performed the tests in a seated position for knee extension and in a standing position for hip extension and hip abduction, using standardized testing positions. For each muscle group, three maximal isometric contractions of 15 seconds were performed, with 2 minutes of rest between trials. Maximal force was defined as the highest peak torque achieved during the contraction. Rate of force development (RFD) was calculated from the slope of the torque-time curve during the initial phase of the contraction (0-200 ms). The best trial was used for analysis. Data were sampled at 100 Hz.

    12 weeks

  • Functional Mobility and Balance

    Time to complete four meters at the preferred gait speed (4MWT).

    12 weeks

  • Functional Mobility and Balance

    Time to complete the Four Square Step Test (FSST).

    12 weeks

  • Functional Mobility and Balance

    Time to stand up and sit down five times (5STS) as quickly as possible.

    12 weeks

  • Functional Mobility and Balance

    Total score of the Mini-BESTest (0-28 points).

    12 weeks

  • Functional Mobility (TUG).

    Time to complete the Timed Up and Go test (seconds).

    12 weeks

  • Functional Mobility under Dual Task

    Time to complete the Timed Up and Go test under dual-task conditions (seconds).

    12 weeks

Secondary Outcomes (4)

  • Feasibility (Recruitment Rate)

    12 weeks

  • Feasibility (Intervention Adherence)

    12 weeks

  • Safety (Adverse Events)

    12 weeks

  • Prospective falls incidence

    6 months

Study Arms (4)

Traditional Resistance Training in Older Fallers

EXPERIMENTAL

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non\_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older fallers will perform a multicomponent exercise program focusing on traditional resistance training.

Behavioral: Multi-component exercise program focused on traditional resistance training

Traditional Resistance Training in Older Non-Fallers

EXPERIMENTAL

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non\_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older non-fallers will perform a multicomponent exercise program focusing on traditional resistance training.

Behavioral: Multi-component exercise program focused on traditional resistance training

Power Training in Older Fallers

EXPERIMENTAL

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non\_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older fallers will perform a multicomponent exercise program focusing on power training.

Behavioral: Multi-component exercise program focused on muscle power

Power Training in Older Non-Fallers

EXPERIMENTAL

Retrospective falls incidence of the 12 months prior to enrollment will be used to divide participants into non\_fallers (n=60) and fallers (n=60) In this arm of the study, 30 older non-fallers will perform a multicomponent exercise program focusing on power training.

Behavioral: Multi-component exercise program focused on muscle power

Interventions

The intervention will be applied for 12 weeks, with a frequency of 3 times per week. Each session will have 45 minutes, and the participants will be instructed to perform a warm-up on a treadmill or other cardiofitness equipment, power training, and balance exercise. Participants in the power training groups (30 non-fallers and 30 fallers) will perform knee extension, hip extension and hip abduction exercises, in a regimen of 3 sets of 10 repetitions at 50% of the participant's 1 repetition maximum (1RM), performing each repetition as fast as possible on variable resistance machines. The 1RM estimation will be determined using a 10RM protocol and applying Brzycki's equation. The 1RM assessment will be conducted during the first training session and will be reassessed every 3 weeks to progressively adjust resistance training loads. The progression on the balance exercise (stepping and manipulation of the centre of mass over the base of support) will be equally performed every 3 weeks.

Also known as: Power Training
Power Training in Older FallersPower Training in Older Non-Fallers

The intervention will be applied for 12 weeks, 3 times per week. Each session will have 45 minutes, and the participants will be instructed to perform a warm-up on a cardiofitness equipment, resistance exercise, and balance exercise. Participants in the traditional resistance training groups (30 non-fallers and 30 fallers) will perform knee extension, hip extension and hip abduction exercises, in a regimen of 3 sets of 10 repetitions at 60-75% of the participant's 1 repetition maximum (1RM), at a cadence of 2s concentric and 2s eccentric on variable resistance machines. The 1RM estimation will be determined using a 10RM protocol and applying Brzycki's equation. The 1RM assessment will be conducted during the first training session and will be reassessed every 3 weeks to progressively adjust resistance training loads. The progression on the balance exercise (stepping and manipulation of the centre of mass over the base of support) will be equally performed every 3 weeks.

Also known as: Traditional Resistance Exercise
Traditional Resistance Training in Older FallersTraditional Resistance Training in Older Non-Fallers

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age between 65-85 years;
  • Fall history over the 12 months prior to enrollment (fallers group).

You may not qualify if:

  • Any existing medical conditions or injuries which would affect the ability or safety to perform exercise;
  • Taking medication affecting balance (such as sedatives, anti-depressives);
  • Regular (more than 1d/week) participation in resistance training with loading greater than bodyweight during the last year;
  • BMI greater than 32 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maia Municipal Sports Hall

Maia, Porto District, Portugal

RECRUITING

Related Publications (21)

  • El-Kotob R, Giangregorio LM. Pilot and feasibility studies in exercise, physical activity, or rehabilitation research. Pilot Feasibility Stud. 2018 Aug 14;4:137. doi: 10.1186/s40814-018-0326-0. eCollection 2018.

    PMID: 30123527BACKGROUND
  • Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.

    PMID: 34207604BACKGROUND
  • Lane C, McCrabb S, Nathan N, Naylor PJ, Bauman A, Milat A, Lum M, Sutherland R, Byaruhanga J, Wolfenden L. How effective are physical activity interventions when they are scaled-up: a systematic review. Int J Behav Nutr Phys Act. 2021 Jan 22;18(1):16. doi: 10.1186/s12966-021-01080-4.

    PMID: 33482837BACKGROUND
  • Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008 Dec;56(12):2234-43. doi: 10.1111/j.1532-5415.2008.02014.x.

    PMID: 19093923BACKGROUND
  • Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.

    PMID: 27707740BACKGROUND
  • Robinovitch SN, Feldman F, Yang Y, Schonnop R, Leung PM, Sarraf T, Sims-Gould J, Loughin M. Video capture of the circumstances of falls in elderly people residing in long-term care: an observational study. Lancet. 2013 Jan 5;381(9860):47-54. doi: 10.1016/S0140-6736(12)61263-X. Epub 2012 Oct 17.

    PMID: 23083889BACKGROUND
  • Mille ML, Johnson-Hilliard M, Martinez KM, Zhang Y, Edwards BJ, Rogers MW. One step, two steps, three steps more ... Directional vulnerability to falls in community-dwelling older people. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1540-8. doi: 10.1093/gerona/glt062. Epub 2013 May 17.

    PMID: 23685768BACKGROUND
  • Hartholt KA, Polinder S, Van der Cammen TJ, Panneman MJ, Van der Velde N, Van Lieshout EM, Patka P, Van Beeck EF. Costs of falls in an ageing population: a nationwide study from the Netherlands (2007-2009). Injury. 2012 Jul;43(7):1199-203. doi: 10.1016/j.injury.2012.03.033. Epub 2012 Apr 27.

    PMID: 22541759BACKGROUND
  • Metter EJ, Conwit R, Tobin J, Fozard JL. Age-associated loss of power and strength in the upper extremities in women and men. J Gerontol A Biol Sci Med Sci. 1997 Sep;52(5):B267-76. doi: 10.1093/gerona/52a.5.b267.

    PMID: 9310077BACKGROUND
  • Fielding RA, LeBrasseur NK, Cuoco A, Bean J, Mizer K, Fiatarone Singh MA. High-velocity resistance training increases skeletal muscle peak power in older women. J Am Geriatr Soc. 2002 Apr;50(4):655-62. doi: 10.1046/j.1532-5415.2002.50159.x.

    PMID: 11982665BACKGROUND
  • Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol (1985). 2002 Oct;93(4):1318-26. doi: 10.1152/japplphysiol.00283.2002.

    PMID: 12235031BACKGROUND
  • Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.

    PMID: 12422327BACKGROUND
  • Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.

    PMID: 20461334BACKGROUND
  • Mehmet H, Robinson SR, Yang AWH. Assessment of Gait Speed in Older Adults. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):42-52. doi: 10.1519/JPT.0000000000000224.

    PMID: 30720555BACKGROUND
  • Inacio M, Creath R, Rogers MW. Low-dose hip abductor-adductor power training improves neuromechanical weight-transfer control during lateral balance recovery in older adults. Clin Biomech (Bristol). 2018 Dec;60:127-133. doi: 10.1016/j.clinbiomech.2018.10.018. Epub 2018 Oct 13.

    PMID: 30343209BACKGROUND
  • Reid KF, Callahan DM, Carabello RJ, Phillips EM, Frontera WR, Fielding RA. Lower extremity power training in elderly subjects with mobility limitations: a randomized controlled trial. Aging Clin Exp Res. 2008 Aug;20(4):337-43. doi: 10.1007/BF03324865.

    PMID: 18852547BACKGROUND
  • Lopes PB, Pereira G, Lodovico A, Bento PC, Rodacki AL. Strength and Power Training Effects on Lower Limb Force, Functional Capacity, and Static and Dynamic Balance in Older Female Adults. Rejuvenation Res. 2016 Oct;19(5):385-393. doi: 10.1089/rej.2015.1764. Epub 2016 Mar 3.

    PMID: 26707497BACKGROUND
  • Inacio M, Ryan AS, Bair WN, Prettyman M, Beamer BA, Rogers MW. Gluteal muscle composition differentiates fallers from non-fallers in community dwelling older adults. BMC Geriatr. 2014 Mar 25;14:37. doi: 10.1186/1471-2318-14-37.

    PMID: 24666603BACKGROUND
  • Rogers MW, Mille ML. Lateral stability and falls in older people. Exerc Sport Sci Rev. 2003 Oct;31(4):182-7. doi: 10.1097/00003677-200310000-00005.

    PMID: 14571957BACKGROUND
  • Kallman DA, Plato CC, Tobin JD. The role of muscle loss in the age-related decline of grip strength: cross-sectional and longitudinal perspectives. J Gerontol. 1990 May;45(3):M82-8. doi: 10.1093/geronj/45.3.m82.

    PMID: 2335723BACKGROUND
  • Aagaard P, Suetta C, Caserotti P, Magnusson SP, Kjaer M. Role of the nervous system in sarcopenia and muscle atrophy with aging: strength training as a countermeasure. Scand J Med Sci Sports. 2010 Feb;20(1):49-64. doi: 10.1111/j.1600-0838.2009.01084.x.

    PMID: 20487503BACKGROUND

Related Links

Central Study Contacts

Óscar J Ribeiro, Master's Degree

CONTACT

Óscar J Ribeiro, Master's Degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: The present project will have a randomized study design with delayed onset with an equal number of elderly individuals with and without a history of falls distributed across the intervention groups. Participants will be tested initially (PRE\_Control), after 12 weeks of control period (PRE\_Intervention), after 12 weeks of intervention (POST\_Intervention), and after 6 months of follow-up (RET).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

September 17, 2024

First Posted

January 27, 2026

Study Start

September 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations