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Physical Activity in Healthy Over 40s

4. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Healthy convenience sample

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Step counts measured by the ActiGraph GT3X+ activity monitor
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Træningskapacitet ved hjælp af Modified Shuttle Test
Tidsramme: Dag 8
Deltagerne vil gennemføre den modificerede shuttletest ved besøg 2 (dag 8).
Dag 8
Stage of Change i form af fysisk aktivitet ved hjælp af Stages of Change-spørgeskemaet
Tidsramme: Dag 8
Deltagerne vil udfylde spørgeskemaet om stadier af forandring ved besøg 2 (dag 8). The Stages of Change Questionnaire er den tidsmæssige del af den transteoretiske model. Det vil blive brugt til at bestemme det aktuelle ændringsstadium, deltageren befinder sig på med hensyn til deres fysiske aktivitetsadfærd.
Dag 8
Step counts measured by the ActivPAL activity monitor
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Judy Bradley, PhD, University of Ulster

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

22. december 2012

Først indsendt, der opfyldte QC-kriterier

28. december 2012

Først opslået (Skøn)

31. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

3
Abonner