Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Eccentric Exercise in Community-dwelling Older Adults (HEX:AGEUK)

29. oktober 2026 opdateret af: Brett Baxter, The University of Northampton

The Effects of an Eccentric-biased Strengthening Programme Delivered to Community-dwelling Older Adults"

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a 12-month eccentric-biased strengthening programme in community-dwelling older adults aged 65 years and older. The main questions it aims to answer are:

Can an eccentric-biased strengthening programme be feasibly delivered to community-dwelling older adults in a community setting? Does participation in the programme improve functional mobility, lower-limb strength, falls self-efficacy, and health-related quality of life?

Participants will:

Attend a 12-month supervised eccentric-biased strengthening programme delivered in a community setting.

Complete assessments of functional mobility, lower-limb strength, falls self-efficacy, and health-related quality of life before and after the intervention.

Provide information regarding their experience of participating in the programme to evaluate its acceptability.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Age-related declines in muscle strength, power, and physical function contribute to reduced mobility, loss of independence, and an increased risk of falls among older adults. Resistance exercise is recommended to mitigate these declines; however, conventional exercise programmes may be limited by physical capacity, fatigue, or accessibility. Eccentric muscle actions allow greater force production at a lower metabolic cost and may therefore represent an effective and practical training modality for older adults.

This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a community-based eccentric-biased strengthening programme delivered to community-dwelling older adults. Participants will be recruited through community organisations and complete a 12-month supervised exercise intervention designed to improve lower-limb strength and functional performance.

Feasibility will be evaluated through recruitment, retention, attendance, adherence, and adverse event monitoring. Acceptability will be assessed through participant feedback and experiences of programme participation. Preliminary effectiveness will be explored through changes in measures of physical function, falls-related self-efficacy, and health-related quality of life collected before and after the intervention.

The findings will provide evidence regarding the practicality of delivering an eccentric-biased strengthening programme within a community setting and will inform the design of future adequately powered controlled studies investigating the effectiveness of eccentric exercise interventions in older adults.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Northamptonshire
      • Northampton, Northamptonshire, Det Forenede Kongerige, NN1 5PH
        • University of Northampton

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Age ≥ 65 years Ambulant with or without a walking aid

Exclusion Criteria:

  • Inability to provide informed consent, assessed using the Mental Capacity Act two-stage assessment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention

Eccentric exercise programme

Participants will undertake a 12-month supervised eccentric-biased strengthening programme delivered in a community setting, with the option of performing this at home. The intervention will consist of 6x 1-minute progressive lower-limb strengthening exercises emphasising the eccentric phase of movement, including functional tasks relevant to activities of daily living. Exercise difficulty will be progressively increased throughout the programme according to participant performance and tolerance. Community sessions will be led by staff at the community setting who will have been educated and trained by developers of the exercise programme in a group-based format. The intervention is designed to improve lower-limb strength, mobility, balance confidence, and physical function in community-dwelling older adults.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Intervention Recruitment
Tidsramme: Up to 12 months

Feasibility of recruitment will be assessed through participant recruitment capacity, calculated as the number of participants enrolled on the study relative to total number of people invited to take part.

Up to 12 months
Feasibility of Intervention Delivery
Tidsramme: Up to 12 months

Feasibility of delivery will be assessed through participant partiicpant adherence to the intervention, calculated as the number of sessions attended relative to the total number of sessions presrcibed.

Up to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timed Up and Go Test
Tidsramme: Up to 12 months

Timed Up and Go test wil require participants to rise from a chair, walk three metres, turn around, return to the chair, and sit down. The time taken to complete the test will be recorded in seconds.

Up to 12 months
Sit-to-stand Test
Tidsramme: Up to 12 months

Lower-limb strength will be assessed using the Five Times Sit-to-Stand test. Participants will be asked to stand up and sit down five times as quickly as possible from a standard chair without using their arms for assistance. Time to completion will be recorded in seconds.

Up to 12 months
Falls Efficacy Scale International
Tidsramme: Up to 12 months

The Falls Efficacy Scale International (FES-I) will be used to assess the fear of falling. The FES-I is a validated self-report questionnaire that evaluates an individual's concern about falling during a range of everyday activities. Higher scores indicate greater concern about falling.

Up to 12 months
EuroQol Five-Dimension Five-Level Questionnaire
Tidsramme: Up to 12 months

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. The instrument evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, alongside a self-rated health visual analogue scale.

Up to 12 months
Intervention Acceptability
Tidsramme: Up to 12 months

Participant acceptability of the eccentric-biased strengthening programme will be assessed through post-intervention feedback. Information regarding participant satisfaction, perceived benefits, barriers to participation, and willingness to continue exercise following programme completion will be collected.

Up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Brett A. Baxter, PhD, University of Northampton

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

23. november 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

22. oktober 2026

Først indsendt, der opfyldte QC-kriterier

29. oktober 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data for all primary and secondary outcome measures reported in study publications will be made available. This includes baseline and post-intervention values for TUG, 5×STS, Short FES-I, EQ-5D-5L, and intervention adherence metrics. No personally identifiable information will be shared.

IPD-delingstidsramme

IPD will be available indefinitely as it will be stored on a public resposiotory (PURE).

IPD-delingsadgangskriterier

Public

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Studiedata/dokumenter

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner