- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07928687
Feasibility Study of an Outdoor Strength Training Program for Older Adults
Development and Implementation of Resistance Training Programs in Community-dwelling Older Adults Using Outdoor Activity Benches: a Feasibility and Pilot Study.
In order to promote healthy ageing and independent living, the World Health Organization recommends older adults to engage in resistance exercise at least twice weekly. However, only a minority of the older population complies with these guidelines, stressing the urgent need to develop comprehensive strategies to implement resistance exercise programs in the community. This PhD project will be performed in close collaboration with IPitup vzw, who developed outdoor activity benches, an accommodating smartphone app with exercise instructions and training courses as a low-cost modality for resistance exercise in the general population. The aim is to build upon these existing structures and develop an optimized, progressive resistance exercise program for community-dwelling older adults, which can be performed in small groups without the need for specialized training experts. The program's feasibility, defined in terms of safety, adherence, usability and acceptability, will be tested.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Prof. Christophe Delecluse
- Numero di telefono: +32 16 32 90 76
- Email: christophe.delecluse@kuleuven.be
Backup dei contatti dello studio
- Nome: Lien Valepyn
- Numero di telefono: +32 488 84 85 97
- Email: lien.valepyn@kuleuven.be
Luoghi di studio
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgio, 3000
- Reclutamento
- KU Leuven - Department of Movement Sciences
-
Contatto:
- Prof. Christophe Delecluse
- Numero di telefono: +32 16 32 90 76
- Email: christophe.delecluse@kuleuven.be
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Community-dwelling adults
- At least 65 years old
Exclusion Criteria:
- Participation in an interventional study with an investigational medicinal product (IMP) or device
- Systematic engagement in resistance exercise during the past year
- Self-reported, unstable cardiovascular disease, neuromuscular disease, acute infection or fever
- Self-reported, surgery in the past year
- Self-reported injuries that result in the inability to perform study-related tasks
- Inability to understand the test and training procedures because of cognitive problems
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Peer-supported outdoor strength training
Participants take part in a 6-week outdoor strength training program using activity benches and a smartphone application. Training is performed in small groups of six community-dwelling older adults. Within each group, one participant acts as a peer coach and provides practical support and motivation. |
2x/week, 35-45min sessions at the outdoor activity bench |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Experiencing Adverse Events
Lasso di tempo: Throughout the 6-week intervention
|
Safety of the intervention, assessed as the number of participants experiencing one or more adverse events related to testing or training sessions during the intervention period. |
Throughout the 6-week intervention
|
|
Participant Adherence Rate
Lasso di tempo: Throughout the 10-week study period
|
Adherence to the intervention, assessed as the proportion of participants who complete the intervention and post-intervention assessments. And assessed as the percentage of scheduled training sessions attended by participants during the 6-week intervention. |
Throughout the 10-week study period
|
|
System Usability Scale (SUS)
Lasso di tempo: Post-intervention at week 9
|
Usability of the intervention will be assessed using the System Usability Scale (SUS), a 10-item questionnaire yielding a total score ranging from 0 to 5. Five items are positively worded, for which higher response scores indicate greater usability, while five items are negatively worded and are reverse-scored, such that lower response scores indicate greater usability. |
Post-intervention at week 9
|
|
Net Promoter Score (NPS)
Lasso di tempo: Post-intervention at week 9
|
Acceptability of the intervention, assessed using the Net Promoter Score (NPS), based on participants' likelihood of recommending the programme to others. Scores range from 0 to 10, with higher scores indicating greater acceptability and willingness to recommend the intervention. |
Post-intervention at week 9
|
|
Participant Acceptability of the Intervention
Lasso di tempo: Post-intervention at week 9
|
Acceptability of the intervention, assessed through participant feedback regarding the peer-led delivery model and the appropriateness of training intensity and progression. Responses will be summarized descriptively. |
Post-intervention at week 9
|
|
Completion Rate of Data Collection Procedures
Lasso di tempo: Over the 10-week study period
|
Feasibility of data collection procedures, assessed as the proportion of planned laboratory-based assessments, questionnaire assessments, and IPitup app-based assessments successfully completed by participants. Higher percentages indicate greater feasibility of the data collection procedures. |
Over the 10-week study period
|
|
Change in Lower Limb Muscle Strength and Power
Lasso di tempo: Baseline at week 1 and post-intervention at week 9
|
Preliminary effects of the intervention on muscle strength and power, assessed as the change in lower limb muscle strength and power from baseline to post-intervention. Muscle strength and power will be measured using the predefined study strength assessment protocol. Higher values indicate greater muscle strength and power. |
Baseline at week 1 and post-intervention at week 9
|
|
Implementation Barriers and Facilitators Identified During Focus Groups
Lasso di tempo: Post-intervention at week 10
|
Implementation barriers and facilitators will be explored through semi-structured focus groups conducted following the intervention. Audio recordings will be transcribed verbatim and analysed using qualitative thematic analysis. Identified barriers and facilitators will be categorized into themes to inform optimization of a future randomized controlled trial. |
Post-intervention at week 10
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
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
Altri numeri di identificazione dello studio
- S71971
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .