Clinical trial NCT01758003: Physical Activity in Healthy Over 40s
Official title: Patterns of Physical Activity in a Healthy Population Aged Over 40 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: Physical Activity
Sedentary Behaviour
Healthy Volunteer
Quality of Life
Exercise Capacity
Transtheoretical Model
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy convenience sample

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Step counts measured by the ActiGraph GT3X+ activity monitor
timeFrame: Seven days
Secondary outcomes:
measure: Step counts measured by the ActivPAL activity monitor
timeFrame: Seven days
measure: Number of steps measured by the Yamax CW-700 DigiWalker pedometer
timeFrame: Seven days
measure: Physical activity levels and sitting time using the International Physical Activity Questionnaire
timeFrame: Day 8
measure: Quality of Life using the EuroQOL-5D-5L
timeFrame: Day 8
measure: Stage of change in terms of physical activity using the Stages of Change Questionnaire
timeFrame: Day 8
measure: Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
timeFrame: Day 8
measure: Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
timeFrame: Day 8
measure: Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
timeFrame: Day 8
measure: Perception of the feasibility and acceptability of the physical activity outcome measures
timeFrame: Day 8
measure: Exercise Capacity using the Modified Shuttle Test
timeFrame: Day 8
Other outcomes:
Locations:
city: Jordanstown
country: United Kingdom
facility: University of Ulster
state: Antrim
Study officials:
affiliation: University of Ulster
name: Judy Bradley, PhD
role: PRINCIPAL_INVESTIGATOR
References: