Physical Activity in Healthy Over 40s

April 4, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Antrim
      • Jordanstown, Antrim, United Kingdom, BT37 0QB
        • University of Ulster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy convenience sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step counts measured by the ActiGraph GT3X+ activity monitor
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity using the Modified Shuttle Test
Time Frame: Day 8
Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).
Day 8
Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time Frame: Day 8
Participants will complete the Stages of Change Questionnaire at Visit 2 (Day 8). The Stages of Change Questionnaire is the temporal part of the transtheoretical model. It will be used to determine the current stage of change the participant is at in terms of their physical activity behaviour.
Day 8
Step counts measured by the ActivPAL activity monitor
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Judy Bradley, PhD, University of Ulster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 22, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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