Eccentric Exercise in Community-dwelling Older Adults (HEX:AGEUK)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Brett A Baxter, PhD
- Numéro de téléphone: 01604892293
- E-mail: brett.baxter@northampton.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Tony Kay, PhD
- Numéro de téléphone: 01604892577
- E-mail: tony.kay@northampton.ac.uk
Lieux d'étude
-
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Northamptonshire
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Northampton, Northamptonshire, Royaume-Uni, NN1 5PH
- University of Northampton
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of Intervention Recruitment
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Timed Up and Go Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Brett A. Baxter, PhD, University of Northampton
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FHSHEA000518
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
IPD will be available indefinitely as it will be stored on a public resposiotory (PURE).
Critères d'accès au partage IPD
Public
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Données/documents d'étude
Informations sur les médicaments et les dispositifs, documents d'étude
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