Physical Activity in Healthy Over 40s

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Judy Bradley, University of Ulster
ClinicalTrials.gov Identifier:
NCT01758003
First received: December 22, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.

Condition
Physical Activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patterns of Physical Activity in a Healthy Population Aged Over 40 Years Old

Resource links provided by NLM:


Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Step counts measured by the ActiGraph GT3X+ activity monitor [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).


Secondary Outcome Measures:
  • Step counts measured by the ActivPAL activity monitor [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    Participants will wear the ActivPAL activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).

  • Number of steps measured by the Yamax CW-700 DigiWalker pedometer [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    Participants will wear the Yamax CW-700 DigiWalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).

  • Physical activity levels and sitting time using the International Physical Activity Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Quality of Life using the EuroQOL-5D-5L [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Participants will complete the EuroQOL-5D-5L at Visit 2 (Day 8).

  • Stage of change in terms of physical activity using the Stages of Change Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Perception of the feasibility and acceptability of the physical activity outcome measures [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.

  • Exercise Capacity using the Modified Shuttle Test [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).


Enrollment: 30
Study Start Date: October 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy convenience sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758003

Locations
United Kingdom
University of Ulster
Jordanstown, Antrim, United Kingdom, BT37 0QB
Sponsors and Collaborators
University of Ulster
Investigators
Principal Investigator: Judy Bradley, PhD University of Ulster
  More Information

No publications provided

Responsible Party: Judy Bradley, Professor of Physiotherapy, University of Ulster
ClinicalTrials.gov Identifier: NCT01758003     History of Changes
Other Study ID Numbers: 12/08
Study First Received: December 22, 2012
Last Updated: April 4, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Ulster:
Physical Activity
Sedentary Behaviour
Healthy Volunteer
Quality of Life
Exercise Capacity
Transtheoretical Model

ClinicalTrials.gov processed this record on September 22, 2014