- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672834
Muscle Function Response to Resistance Band Training in Older Adults With Impaired Muscle Power
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel C Low, Doctor of Philosophy
- Phone Number: +44 01895 268931
- Email: Daniel.low@brunel.ac.uk
Study Locations
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-
-
London, United Kingdom, UB8 3PH
- Recruiting
- Department of Sport, Health, and Exercise Sciences
-
Contact:
- Laura Hills, Doctor of Philosophy
- Phone Number: +44 (0)1895 267369
- Email: Laura.hills@brunel.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be of male or female sex and free from known neurological health conditions (e.g. Peripheral Neuropathy, Parkinson's Disease, Stroke, Migraines, Epilepsy) or musculoskeletal injury.
- low muscle power determined as a score of 8.1 and 9 seconds or more for the completion of the 5 times sit to stand test for males and females respectively
Exclusion Criteria:
- Neurological health condition or musculoskeletal injury at the time of baseline testing
- individuals aged under 50
- individuals who have been told to avoid strenuous physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance band group, with fitness advice
|
Participants will be given a resistance band and at set of exercises that target the lower extremities and asked to perform these as three sets of 15 repetitions, 2 times a week.
Participants will be undertake a series of functional fitness tests and have their performance evaluated against normative values for their age and sex.
Following this advice will be given with the aim of empowering change in physical activity participation.
|
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No Intervention: Normal life
|
|
|
Experimental: Resistance band without fitness advice
|
Participants will be given a resistance band and at set of exercises that target the lower extremities and asked to perform these as three sets of 15 repetitions, 2 times a week.
|
|
Experimental: Fitness advice
|
Participants will be undertake a series of functional fitness tests and have their performance evaluated against normative values for their age and sex.
Following this advice will be given with the aim of empowering change in physical activity participation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Five times sit to stand time
Time Frame: After 12 weeks
|
Sitting on a chair, participants stand to full leg extension, and then return to a seated position 5 times, and the time taken recorded in seconds.
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After 12 weeks
|
|
Single leg stand time
Time Frame: After 12 weeks
|
This is the length of time, in seconds, an individual can stand on a single leg for as long as possible (up to a maximum of 90 seconds)
|
After 12 weeks
|
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Timed up and go
Time Frame: After 12 weeks
|
This is the time, in seconds, it takes for an individual to stand from a seated position, without using their hands, walk around a cone which is 3 meters away, before returning to the seated position.
|
After 12 weeks
|
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Postural sway
Time Frame: after 12 weeks
|
Using a force plate recording at 100Hz for 30 seconds, 5 eyes open and eyes closed trials will be recorded at baseline and after 12 weeks of resistance band exercises.
Using the Centre of Pressure measurements provided.
Linear (e.g. total sway path length and sway path in the medio-lateral and anterior-posterior directions, measured in meters) and non-linear (fractal dimension, unitless measurement units) postural control measurements will be calculated.
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle power
Time Frame: After 12 weeks
|
Using a Biodex dynamometer, 5 practice and 5 trial concentric muscle efforts will be performed with the peak torque (newton meters), time to peak torque (seconds) and peak torque (newton meters) at 0.18 seconds will be recorded.
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After 12 weeks
|
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Grip strength
Time Frame: After 12 weeks
|
using and hand strength dynamometer, grip strength will be measured as the maximum value of 2 maximal efforts using their dominant hand.
This is measured in kilograms.
|
After 12 weeks
|
|
Fear of falling
Time Frame: After 12 weeks
|
Falls efficacy scale - international questionnaire (https://sites.manchester.ac.uk/fes-i).
The total score of questions will be used in the analysis.
|
After 12 weeks
|
|
Self-efficacy for exercise
Time Frame: After 12 weeks
|
Self-efficacy for exercise questionnaire (SEE) (https://www.sralab.org/sites/default/files/2017-06/Self-efficacy%20for%20exercise_Website_PDF.pdf). The total score of 9 questions will be used in the analysis. The Scale: Each question is rated from 0 (Not Confident) to 10 (Very Confident). Scoring: Add the numbers for all 9 responses together. Range: Total scores range from 0 to 90. Interpretation: Higher totals indicate a greater level of self-efficacy (stronger belief in your ability to maintain an exercise routine). |
After 12 weeks
|
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Perceived change in body, balance and power
Time Frame: After 12 weeks
|
Using a 15 point Likert Global Rating of Change scale (GRC) to measure perceived change. +7 to +1: Ranging from "A very great deal better" (+7) to "A little better" (+1) 0: No change -1 to -7: Ranging from "A little worse" (-1) to "A very great deal worse" (-7) This scale will be completed for the measurement of perceived change in body, balance and power separately (i.e. there will be a separate scores given for each domain). |
After 12 weeks
|
|
Quality of life
Time Frame: 12 weeks
|
The Older People Quality of Life questionnaire (OPQOL) will be completed (https://ilcuk.org.uk/wp-content/uploads/2019/03/OPQOL-full-questionnaire.pdf). Each subsection of the OPQOL will be analysed separately. This is scored on a 5 point scale 1 = very good to 5 = very bad. The scores are reversed so that a higher value suggests better quality of life. In each subsection values are summed. Subsections Live overall = min score is 4 and max score is 20 Health = min score is 4 and max score is 20 Social relationships = min score is 5 and max score is 25 Independence, control over life, freedom = min score is 4 and max score is 20 Home and neighbourhood = min score is 4 and max score is 20 Financial circumstances = min score is 4 and max score is 20 Leisure and activities = min score is 6 and max score is 30 |
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- 51560-A-May/2026- 55297-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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