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L'essai clinique NCT06100445 pour Blessure musculosquelettique, Fragilité, Inactivité physique, Comportement de santé est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Exercise Engagement in People Over 60 at Risk of Falls

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06100445 est un essai observationnel pour Blessure musculosquelettique, Fragilité, Inactivité physique, Comportement de santé. Son statut actuel est : en recrutement. L'étude a débuté le 26 janvier 2024 et vise à recruter 10 participants. Dirigé par East Lancashire Hospitals NHS Trust, l'essai devrait être terminé d'ici le 31 décembre 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 juin 2024.
Résumé succinct
It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise.

Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls.

To explore:

  1. Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts
  2. The ability to discuss falls risk with health professionals.
  3. If health inequalities exist with people at risk of falls and exercising.
  4. Sustainability of exercise, in order to reduce the risk of falls in this population.
  5. The need to develop MSK internal and external facing falls management pathways.

Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale.

'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination.

Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.

Description détaillée
One in three people over the age of 65 and one in two over the age of 80 will fall each year. A fall is the main reason older people attend A and E. Falls can result in soft tissue injuries and broken bones, the most significant being a hip fracture, and these often require physiotherapy input. Locally, we have above average rates of hip fracture. Falling also reduces confidence and further mobility, which can also impact on developing long term health conditions.

Research has shown that exercise can help improve the strength and balance in people over 60 at risk of falls. Balance and strength exercises have been shown in previous research to reduce the risk of falls by 25% in patient's over 60. However, in other research, 78% of patients over the age of 75 have not done exercises at home in the last 5 years.

Exploring patient views on exercises and their physiotherapy experience will help us understand why patients engage or not with exercise and improve our services.

Patients who are at risk (identified through the EMIS template) of falls and have expressed an interest in being involved in research and who meet the additional eligibility criteria will be approached by the researcher. Eligible participants interested in participating will be contacted and sent the patient information sheet and consent form. They will be contacted within two weeks to see if they want to participate and assistance with the consent form either over phone or face to face.

A copy of the consent form will be scanned into the participant notes on EMIS, and paper copies stored securely in a locked filing cabinet.

All participants will have the opportunity to ask any questions regarding consent and the study prior to commencing the interviews and data collection.

The right of the participant to refuse to participate in research study without giving reasons will be respected. All participants are free to withdraw at any time without giving reasons and without prejudicing further treatment.

Face to face interviews will be recorded via an encrypted voice Dictaphone recorder. If conducting interviews via telephone call or MS teams, then voice recordings using the encrypted dictaphone will also be used. The interview will take approximately half an hour, and patients will only be interviewed once, there will be no follow up in this study.

All participant identifiable information will be kept confidential, and a participant number will be used. Recordings will be loaded onto a password protected secure trust server, accessible only to the researcher and the original recording deleted off the Dictaphone within 48 hours (about 2 days). Once transcribed, the recording on the drive will then be deleted.

Anonymised qualitative data will be transcribed by an NIHR transcriber. Then it will be analysed using thematic analysis using NVivo version 12, or the most up to date version of NVivo, a qualitative data analysis software. All data will be anonymised prior to analysis using an allocated participant ID number.

In the unlikely event that distress will be identified, the interview will be stopped, and the reason for the distress dealt with as per normal clinical practice. The participant will be given the option to stop participating (see withdrawal from participating below), or to continue with the interview at a later time. Participants can withdraw at any time up to once the interviews have been transcribed.

Data will then be used to improve patient services in physiotherapy, as well as highlight any service pathway and health inequality needs.

Titre officiel

Barriers and Facilitators to Exercise Engagement in People Over 60 at Risk of Falls: an Exploratory Study

Conditions
Blessure musculosquelettiqueFragilitéInactivité physiqueComportement de santé
Autres identifiants de l'essai
  • DEV072
Numéro NCT
Date de début (réel)
2024-01-26
Dernière mise à jour publiée
2024-06-21
Date de fin (estimée)
2024-12-31
Inscription (estimée)
10
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
N/A
Semi Structured Interviews
Gaining qualitative data
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Explore reasons for and against engaging with exercises at home.
By identifying themes during anaylsis of study interviews
Through study completion, an average of 1 year
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Patients' thoughts on service materials, provision and communication
Identify preferred exercise format and understanding of information eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or their own online personalised rehabilitation programme handouts by analysing themes of the interviews
Through study completion, an average of 1 year
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
60 Years
Sexes éligibles
Tous
  • Aged 60 years or over
  • At risk of falls or had a fall due to a musculoskeletal cause (pain, muscle weakness, balance issue)
  • Has capacity to consent, as deemed by the direct care team and researcher
  • Can communicate in English OR the use of a translation service - Able to independently participate in an interview either face-to-face or via remote means OR can use a translation service

- Aged under 60

  • Have a medical cause of falls OR currently under investigation for a medical cause of falls (eg/ dizziness, cardiac, visual impairment reported as being the cause of the fall as opposed to weakness or pain in lower limbs/balance issues or unsteady on feet)
  • Moderate to severe cognitive impairment impairing capacity to consent
East Lancashire Hospitals NHS Trust logoEast Lancashire Hospitals NHS Trust
National Institute for Health Research, United Kingdom logoNational Institute for Health Research, United Kingdom
Partie responsable de l'essai
Michelle Thirlwall, Investigateur principal, Principal Investigator, East Lancashire Hospitals NHS Trust
Contact central de l'essai
Contact: Michelle Thirlwall, 01706 235398, [email protected]
Contact: Michelle Stephens, 07976152397, [email protected]
1 Centres de l'essai dans 1 pays

Lancashire

East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, BB2 3HH, United Kingdom
Michelle Thirlwall, Contact
En recrutement