- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07916935
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brett A Baxter, PhD
- Phone Number: 01604892293
- Email: brett.baxter@northampton.ac.uk
Study Contact Backup
- Name: Tony Kay, PhD
- Phone Number: 01604892577
- Email: tony.kay@northampton.ac.uk
Study Locations
-
-
Northamptonshire
-
Northampton, Northamptonshire, United Kingdom, NN1 5PH
- University of Northampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention Recruitment
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brett A. Baxter, PhD, University of Northampton
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHSHEA000518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Time Frame
IPD will be available indefinitely as it will be stored on a public resposiotory (PURE).
IPD Sharing Access Criteria
Public
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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