The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.
Evaluation of the Feasibility, Psychosocial Effects, Influence and Perception of Exercise Selection and Experimental Design of Exercises Performed.
Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions.
The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults.
The study will establish the accessibility, acceptability and appropriateness of an elastic band exercise intervention with older adults by performing selected activities followed by researcher led interviews that will focus on the participants influences, perceptions and psycho-social factors related the intervention activities.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Outline of study design The following study will be designed as a single exposure, qualitative (one-to-one interviews using a semi-structured interview guide) and quantitative (heart rate and rate of perceived exertion ratings) study. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will take part in one experimental session: performing exercises with an elastic resistance band placed at the hip and chest region. The session order of band placement will be randomized for each participant to counter-balance the outcome which emerge from the study.
Participant preparation Following a detailed briefing using a pre-prepared participant information sheet, a signed informed consent form and Instrumental Activities of Daily Living form, participants will be required to complete 2 supervised visits to the laboratory at the University of Derby.
Participants will complete a general health screening questionnaire. Specific instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation.
Outline of study methods Participants will be required to attend the University Laboratory (Kblock) to take part in the study. Due to COVID-19 participants will be required to adhere to the latest government guidance and guidance from the University to consider this assessment to be safe (Risk assessments in place).
Baseline assessments:
- Mini Balance Evaluation (MINI BESTest)
- Short Falls Efficacy Scale (Short FES-I)
Following a briefing, participants will be required to perform a 10 minute supervised warm up and mobility session prior to exercise. Participants will be required to perform a selection of 8 pre-selected exercises whilst wearing the elastic band around the hip or chest region (randomized) with a 20 minute rest in between each condition). Participants will perform the exercises with the lowest resistance of 2-15lb aimed at low/moderate intensity. Heart rate (HR) on a heart rate strap and watch, rate of perceived exertion (RPE) (Borg scale) will be measured to assess exercise intensity.
All sessions will be closely supervised by the lead researcher -a qualified postural stability instructor, (level 4 reps Postural Stability Instructor trained by Later Life Training), that will provide prompts on form of the exercises.
Elastic band placement
Hip region:
Each participant will be required to perform the series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level which will be attached to the participant over the hip region with padding.
Chest region Each participant will be required to perform a series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level and to the participant over the chest region (under arms) , using Velcro on a chest harness/training vest.
Immediately following the single-session exercise intervention, participants will be required to attend a one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Derby, Regno Unito, de22 11gb
- Reclutamento
- University of Derby
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
- Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
- Ability to walk without a walking aid
- Ability to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired
Exclusion Criteria:
- Individuals that are under the age of 50 years old
- Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
- Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are not physically active (METs score under 600 MET-min/week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
- Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Hip Region
Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed around the hip region. Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Semi-structured Interview schedule |
A single exposure feasibility study using elastic resistance bands in older adults to challenge stability.
Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled.
A semi- structured interview will identify the impact and practicalities of the intervention.
The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.
Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
Altri nomi:
|
|
Sperimentale: Chest Region
Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest). Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Semi-structured Interview schedule |
A single exposure feasibility study using elastic resistance bands in older adults to challenge stability.
Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled.
A semi- structured interview will identify the impact and practicalities of the intervention.
The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.
Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Semi structured Interview
Lasso di tempo: through study completion, an average of 1 year
|
A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention.
The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.
A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol.
Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement.
This will help to build insights into the participant preferences which is an important element of the intervention design.
|
through study completion, an average of 1 year
|
|
Frequenza cardiaca
Lasso di tempo: attraverso il completamento degli studi, una media di 1 anno
|
Le misurazioni della frequenza cardiaca saranno prese durante ogni esercizio.
Valori più alti = sforzo maggiore per ogni esercizio eseguito.
50 battiti al min - 120 = bassi, 120-150 battiti al min = moderati e 150 battiti al min = alti.
|
attraverso il completamento degli studi, una media di 1 anno
|
|
Rate of perceived exertion (RPE)
Lasso di tempo: through study completion, an average of 1 year
|
RPE measures will be taken during each exercise.
Scale 0-10.
0= no exertion and 10 being the highest exertion- exhaustion.
|
through study completion, an average of 1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Test di valutazione della mini bilancia (MINI-BESTest)
Lasso di tempo: attraverso il completamento degli studi, una media di 1 anno
|
Questa valutazione richiederà ai partecipanti di eseguire una serie di compiti di prestazione fisica. Dopo ogni attività, il ricercatore registrerà i punteggi per sommare un punteggio totale per il MINI BESTest. Punteggio: il test ha un punteggio massimo di 28 punti su 14 elementi, ciascuno con un punteggio da 0 a 2. "0" = livello minimo di funzione e "2" = livello massimo di funzione. Se un soggetto deve utilizzare un dispositivo di assistenza per un oggetto, assegna a quell'oggetto un punteggio inferiore di una categoria. Se un soggetto richiede assistenza fisica per eseguire un oggetto, punteggio "0" per quell'oggetto. |
attraverso il completamento degli studi, una media di 1 anno
|
|
Short Falls efficacy scale
Lasso di tempo: through study completion, an average of 1 year
|
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities.
The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item.
A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).
|
through study completion, an average of 1 year
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Forma Attività Strumentali della Vita Quotidiana (IADL)
Lasso di tempo: attraverso il completamento degli studi, una media di 1 anno
|
Identificare come una persona sta funzionando al momento per determinare eventuali differenze nel reclutamento della partecipazione. L'IADL ha 8 categorie in cui il partecipante è tenuto a selezionare una delle quattro opzioni che hanno un punteggio assegnato al proprio livello di funzionamento (1 o 0). Interpretazione del punteggio: in alcune attività e categorie, solo la funzione di livello più alto riceve un 1; in altri, due o più livelli hanno punteggi pari a 1 perché ciascuno descrive una competenza che rappresenta un livello minimo di funzione. Queste schermate sono utili per indicare specificamente come si sta comportando una persona in questo momento. Pertanto un punteggio più alto sulla IADL rappresenterebbe un livello di funzionamento più elevato. Punteggio più alto = 8 (alto funzionamento), punteggio più basso = 0 (basso funzionamento). |
attraverso il completamento degli studi, una media di 1 anno
|
|
International physical activity questionnaire (IPARQ)
Lasso di tempo: through study completion, an average of 1 year
|
IPAQ assesses physical activity undertaken across a set of domains. The following values are used for the analysis: Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. Low= Individuals who not meet criteria for Categories 2 or 3 are considered to have a 'low' physical activity level. Moderate= a) 3 or more days of vigorous-intensity activity of at least 20 minutes per day b) 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day c) 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week. High= a) vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week b) 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum Total physical activity of at least 3000 MET-minutes/week. |
through study completion, an average of 1 year
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Andy Pringle, PhD, University of Derby
Pubblicazioni e link utili
Pubblicazioni generali
- Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
- Carroll TJ, Barry B, Riek S, Carson RG. Resistance training enhances the stability of sensorimotor coordination. Proc Biol Sci. 2001 Feb 7;268(1464):221-7.
- Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.
- Colado JC, Triplett NT. Effects of a short-term resistance program using elastic bands versus weight machines for sedentary middle-aged women. J Strength Cond Res. 2008 Sep;22(5):1441-8. doi: 10.1519/JSC.0b013e31817ae67a.
- Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.
- Gerards MHG, McCrum C, Mansfield A, Meijer K. Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice. Geriatr Gerontol Int. 2017 Dec;17(12):2294-2303. doi: 10.1111/ggi.13082. Epub 2017 Jun 16.
- Lima FF, Camillo CA, Gobbo LA, Trevisan IB, Nascimento WBBM, Silva BSA, Lima MCS, Ramos D, Ramos EMC. Resistance Training using Low Cost Elastic Tubing is Equally Effective to Conventional Weight Machines in Middle-Aged to Older Healthy Adults: A Quasi-Randomized Controlled Clinical Trial. J Sports Sci Med. 2018 Mar 1;17(1):153-160. eCollection 2018 Mar.
- Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
- Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
- Youdas JW, Adams KE, Bertucci JE, Brooks KJ, Nelson MM, Hollman JH. Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance. J Sport Rehabil. 2014 Feb;23(1):1-11. doi: 10.1123/jsr.2012-0082. Epub 2013 Aug 6.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UDerby
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 .
Prove cliniche su Vecchiaia; Debolezza
-
Women and Infants Hospital of Rhode IslandNon ancora reclutamentoDiabete gestazionale | Piccolo per età gestazionale | Ipoglicemia neonatale | Obesità materna che complica la gravidanza | Age grande per gestazionale