Physical ActivityNCT01758003
Physical Activity in Healthy Over 40s
An observational study of Physical Activity, run by University of Ulster at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy convenience sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Ulster
Jordanstown, Antrim, BT37 0QB
About this study
Official title: 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:
- 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.
- To explore physical activity levels, exercise capacity and quality of life in a healthy population age-matched to a population with bronchiectasis.
- 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.
Read the 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.
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Sedentary Behaviour, Healthy Volunteer, Quality of Life, Exercise Capacity, Transtheoretical Model
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts measured by the ActiGraph GT3X+ activity monitor
Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Measured: Seven days
Secondary outcomes (10)
Step counts measured by the ActivPAL activity monitor
Participants will wear the ActivPAL activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Measured: Seven days
Number of steps measured by the Yamax CW-700 DigiWalker pedometer
Participants will wear the Yamax CW-700 DigiWalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Measured: Seven days
Physical activity levels and sitting time using the International Physical Activity Questionnaire
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.
Measured: Day 8
Quality of Life using the EuroQOL-5D-5L
Participants will complete the EuroQOL-5D-5L at Visit 2 (Day 8).
Measured: Day 8
Stage of change in terms of physical activity using the Stages of Change Questionnaire
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.
Measured: Day 8
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
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.
Measured: Day 8
Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
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.
Measured: Day 8
Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
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.
Measured: Day 8
Perception of the feasibility and acceptability of the physical activity outcome measures
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.
Measured: Day 8
Exercise Capacity using the Modified Shuttle Test
Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Bradley, University of Ulster
- Investigators
- Judy Bradley, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758003
- Sponsor's protocol ID
- 12/08
- Status last verified
- Apr 2014
- First submitted
- 22 Dec 2012
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Physical Activity in a Healthy Population Aged Over 40 Years Old
- ClinicalTrials.gov ID
- NCT01758003
- Acronym / sponsor ID
- 12/08
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Sedentary Behaviour, Healthy Volunteer, Quality of Life, Exercise Capacity, Transtheoretical Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To explore physical activity levels, exercise capacity and quality of life in a healthy population age-matched to a population with bronchiectasis.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy convenience sample
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
10 secondary outcomes
Step counts measured by the ActivPAL activity monitor
Time frame: Seven days
Number of steps measured by the Yamax CW-700 DigiWalker pedometer
Time frame: Seven days
Physical activity levels and sitting time using the International Physical Activity Questionnaire
Time frame: Day 8
Quality of Life using the EuroQOL-5D-5L
Time frame: Day 8
Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time frame: Day 8
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Time frame: Day 8
Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
Time frame: Day 8
Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
Time frame: Day 8
Perception of the feasibility and acceptability of the physical activity outcome measures
Time frame: Day 8
Exercise Capacity using the Modified Shuttle Test
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Bradley, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step counts measured by the ActiGraph GT3X+ activity monitor (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.