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The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.

6 de agosto de 2021 actualizado por: Nichola Davis, University of Derby

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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Anticipado)

15

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Derby, Reino Unido, de22 11gb
        • Reclutamiento
        • University of Derby

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otros nombres:
  • Entrenamiento con banda de resistencia elástica
  • Entrenamiento del equilibrio en Adultos Mayores
  • Entrenamiento de Estabilidad con Bandas de Resistencia en Adultos Mayores
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • Novedosa Intervención de Entrenamiento con Banda de Resistencia Elástica en Adultos Mayores
  • Feasibility study on a Novel Elastic Resistance Band training Intervention
Experimental: 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.
Otros nombres:
  • Entrenamiento con banda de resistencia elástica
  • Entrenamiento del equilibrio en Adultos Mayores
  • Entrenamiento de Estabilidad con Bandas de Resistencia en Adultos Mayores
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • Novedosa Intervención de Entrenamiento con Banda de Resistencia Elástica en Adultos Mayores
  • Feasibility study on a Novel Elastic Resistance Band training Intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Semi structured Interview
Periodo de tiempo: 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
Ritmo cardiaco
Periodo de tiempo: hasta la finalización de los estudios, un promedio de 1 año
Se tomarán medidas de frecuencia cardíaca durante cada ejercicio. Valores más altos = mayor esfuerzo de cada ejercicio realizado. 50 latidos por minuto - 120 = bajo, 120-150 latidos por minuto = moderado y 150 latidos por minuto = alto.
hasta la finalización de los estudios, un promedio de 1 año
Rate of perceived exertion (RPE)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prueba de evaluación de mini balanza (MINI-BESTest)
Periodo de tiempo: hasta la finalización de los estudios, un promedio de 1 año

Esta evaluación requerirá que los participantes realicen una serie de tareas de rendimiento físico. Después de cada tarea, el investigador registrará las puntuaciones para sumar una puntuación total para el MINI BESTest. Puntaje: La prueba tiene un puntaje máximo de 28 puntos de 14 ítems, cada uno de los cuales se califica de 0 a 2. "0" = nivel de función más bajo y "2" = nivel de función más alto.

Si un sujeto debe usar un dispositivo de asistencia para un elemento, puntúe ese elemento en una categoría más baja.

Si un sujeto requiere asistencia física para realizar un ítem, puntúe "0" para ese ítem.

hasta la finalización de los estudios, un promedio de 1 año
Short Falls efficacy scale
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Formulario de Actividades Instrumentales de la Vida Diaria (AIVD)
Periodo de tiempo: hasta la finalización de los estudios, un promedio de 1 año

Para identificar cómo está funcionando una persona en el momento actual para determinar cualquier diferencia en el reclutamiento de participación. La IADL tiene 8 categorías en las que el participante debe seleccionar una de las cuatro opciones que tienen un puntaje asignado a su nivel de funcionamiento (ya sea 1 o 0). Interpretación de la puntuación: en algunas actividades y categorías, solo el nivel más alto de función recibe un 1; en otros, dos o más niveles tienen puntajes de 1 porque cada uno describe una competencia que representa algún nivel mínimo de función.

Estas pantallas son útiles para indicar específicamente cómo se está desempeñando una persona en el momento actual. Por lo tanto, una puntuación más alta en la IADL representaría un nivel de funcionamiento más alto. Puntuación más alta = 8 (funcionamiento alto), puntuación más baja = 0 (funcionamiento bajo).

hasta la finalización de los estudios, un promedio de 1 año
International physical activity questionnaire (IPARQ)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Andy Pringle, PhD, University of Derby

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de agosto de 2021

Finalización primaria (Anticipado)

1 de octubre de 2021

Finalización del estudio (Anticipado)

1 de octubre de 2021

Fechas de registro del estudio

Enviado por primera vez

6 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2021

Publicado por primera vez (Actual)

21 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UDerby

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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