- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07672834
Muscle Function Response to Resistance Band Training in Older Adults With Impaired Muscle Power
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Daniel C Low, Doctor of Philosophy
- Numero di telefono: +44 01895 268931
- Email: Daniel.low@brunel.ac.uk
Luoghi di studio
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London, Regno Unito, UB8 3PH
- Reclutamento
- Department of Sport, Health, and Exercise Sciences
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Contatto:
- Laura Hills, Doctor of Philosophy
- Numero di telefono: +44 (0)1895 267369
- Email: Laura.hills@brunel.ac.uk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Resistance band group, with fitness advice
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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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Nessun intervento: Normal life
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Sperimentale: Resistance band without fitness advice
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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.
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Sperimentale: Fitness advice
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Five times sit to stand time
Lasso di tempo: After 12 weeks
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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
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Single leg stand time
Lasso di tempo: After 12 weeks
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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)
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After 12 weeks
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Timed up and go
Lasso di tempo: After 12 weeks
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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.
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After 12 weeks
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Postural sway
Lasso di tempo: after 12 weeks
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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.
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after 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Muscle power
Lasso di tempo: After 12 weeks
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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
Lasso di tempo: After 12 weeks
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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.
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After 12 weeks
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Fear of falling
Lasso di tempo: After 12 weeks
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Falls efficacy scale - international questionnaire (https://sites.manchester.ac.uk/fes-i).
The total score of questions will be used in the analysis.
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After 12 weeks
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Self-efficacy for exercise
Lasso di tempo: After 12 weeks
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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
Lasso di tempo: After 12 weeks
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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
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Quality of life
Lasso di tempo: 12 weeks
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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
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 51560-A-May/2026- 55297-1
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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