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Physical Activity in Healthy Over 40s

4 de abril de 2014 actualizado por: Judy Bradley, University of Ulster

Patterns of Physical Activity in a Healthy Population Aged Over 40 Years Old

The primary aim of this research is to examine physical activity in a healthy population aged over 40 years old.

Subsidiary aims of this research are:

  1. To establish normative values for physical activity levels, exercise capacity, quality of life and readiness to change physical activity behaviour (stages of change, self-efficacy, decisional balance and processes of change) in a healthy population age-matched to a population with bronchiectasis.
  2. To explore physical activity levels, exercise capacity and quality of life in a healthy population age-matched to a population with bronchiectasis.
  3. To explore readiness to change physical activity behaviour (stages of change, self-efficacy, processes of change and decisional balance) in a healthy population compared to a population with bronchiectasis.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The current study is running alongside an externally funded project measuring physical activity levels in patients with bronchiectasis (ClinicalTrials.gov ID: NCT01569009). In order to more fully understand physical activity behaviours in bronchiectasis, it is important to compare the patterns of physical activity, exercise capacity and quality of life of the patients with bronchiectasis to a healthy age-matched population.

For a healthy population of similar age to patients with bronchiectasis, little applicable research currently exists with regard to normative values of physical activity and sedentary behaviour. In this particular study, we will measure physical activity levels in healthy individuals age-matched to patients with bronchiectasis. The most commonly used questionnaire to assess physical activity is the International Physical Activity Questionnaire. Pedometers are inexpensive devices which can be used to assess daily step count and time spent in walking. Activity monitors are more expensive and require technical expertise for analysis and interpretation. However, they provide more in-depth information on pattern, quantity and intensity of activity including daily sedentary time. In this study, the investigators will use the ActiGraph activity monitor, ActivPAL activity monitor, DigiWalker pedometer and IPAQ to measure the physical activity levels in healthy individuals age-matched to patients with bronchiectasis. This study will not focus on participants who engage in high levels of physical activity as they are unlikely to represent the physical activity levels of patients with bronchiectasis.

This study will include the Modified Shuttle Test. Exercise capacity measured by the Modified Shuttle Test is normally only utilized in respiratory disease populations such as patients with cystic fibrosis. However, it has recently been highlighted that there is a need for reference data in healthy populations. This study will also use the EQ-5D-5L questionnaire to assess quality of life. Preliminary testing of the EQ-5D-5L questionnaire, an update to the well-researched EQ-5D-3L, has only recently been conducted. There is a need for studies to provide more normative data on the EQ-5D-5L.

This study will also assess readiness to change physical activity behaviour in a healthy population utilising transtheoretical model components such as stages of change, self-efficacy, decisional balance and processes of change; which have all been shown to be important in physical activity behaviour. Understanding healthy individuals' perspectives on readiness to change physical activity behaviour and the links between important outcomes will help to inform future physical activity interventions.

Tipo de estudio

De observación

Inscripción (Actual)

30

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

    • Antrim
      • Jordanstown, Antrim, Reino Unido, BT37 0QB
        • University of Ulster

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

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy convenience sample

Descripción

Inclusion Criteria:

  • aged ≥ 40 years
  • does not participate in regular exercise or participates in regular exercise at a moderate level ≤ 3 hours/week
  • ≤ 10 pack-year history of smoking
  • does not suffer from any concomitant condition which may prevent participation in physical activity
  • answered 'No' to all questions in the Medical Questionnaire

Exclusion Criteria:

  • participates in regular exercise at a moderate level > 3 hours/week
  • pregnancy
  • any concomitant condition which may prevent participation in physical activity
  • answered 'Yes' to any questions in the Medical Questionnaire

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Step counts measured by the ActiGraph GT3X+ activity monitor
Periodo de tiempo: Seven days
Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Seven days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Capacidad de ejercicio utilizando la prueba de lanzadera modificada
Periodo de tiempo: Día 8
Los participantes completarán la prueba de traslado modificada en la visita 2 (día 8).
Día 8
Etapa de cambio en términos de actividad física utilizando el Cuestionario de Etapas de Cambio
Periodo de tiempo: Día 8
Los participantes completarán el Cuestionario de Etapas de Cambio en la Visita 2 (Día 8). El Cuestionario de Etapas de Cambio es la parte temporal del modelo transteórico. Se utilizará para determinar la etapa actual de cambio en la que se encuentra el participante en términos de su comportamiento de actividad física.
Día 8
Step counts measured by the ActivPAL activity monitor
Periodo de tiempo: Seven days
Participants will wear the ActivPAL activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Seven days
Number of steps measured by the Yamax CW-700 DigiWalker pedometer
Periodo de tiempo: Seven days
Participants will wear the Yamax CW-700 DigiWalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Seven days
Physical activity levels and sitting time using the International Physical Activity Questionnaire
Periodo de tiempo: Day 8
Participants will complete the International Physical Activity Questionnaire at Visit 2 (Day 8). It will be used to measure participants' time spent in physical activity in the last seven days and also to provide self-reported sitting time.
Day 8
Quality of Life using the EuroQOL-5D-5L
Periodo de tiempo: Day 8
Participants will complete the EuroQOL-5D-5L at Visit 2 (Day 8).
Day 8
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Periodo de tiempo: Day 8
Participants will complete Marcus's Self-Efficacy Questionnaire at Visit 2 (Day 8). Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model. It will provide more detailed information on each individual's confidence to undertake physical activity in different situations.
Day 8
Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
Periodo de tiempo: Day 8
Participants will complete Marcus's Decisional Balance Questionnaire at Visit 2 (Day 8). Marcus's Decisional Balance Questionnaire is a component of the transtheoretical model. It will assess each individual's perceptions of the benefits and negative aspects of physical activity.
Day 8
Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
Periodo de tiempo: Day 8
Participants will complete Marcus's Processes of Change Questionnaire at Visit 2 (Day 8). Marcus's Processes of Change Questionnaire is a component of the transtheoretical model. It describes the strategies and techniques individuals use to progress through the different stages of change.
Day 8
Perception of the feasibility and acceptability of the physical activity outcome measures
Periodo de tiempo: Day 8
The researcher and the participants will answer the feasibility and acceptability questions at Visit 2 (Day 8). The feasibility and acceptibility questions were designed for this study to assess the researchers' and participants' perspectives of the feasibility and acceptability of the physical activity outcome measures (ActiGraph, ActivPAL, pedometer and International Physical Activity Questionnaire.
Day 8

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Judy Bradley, PhD, University of Ulster

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

1 de octubre de 2012

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de abril de 2014

Fechas de registro del estudio

Enviado por primera vez

22 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

28 de diciembre de 2012

Publicado por primera vez (Estimar)

31 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de abril de 2014

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

4 de abril de 2014

Última verificación

1 de abril de 2014

Más información

Términos relacionados con este estudio

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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