NCT02928913

Brief Summary

To investigate associations between sedentary and active behaviour with bone health and functional ability, and to associate mechanical loading at the lumbar spine and hip in sedentary and active individuals with bone mineral density.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 5, 2016

Last Update Submit

October 25, 2017

Conditions

Bone Health

Keywords

sedentarynon-sedentarypopulations

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    One day

Secondary Outcomes (8)

  • Mechanical loading dose during daily activity via accelerometry

    7 days

  • Mechanical loading intensity during daily activity via accelerometry

    7 days

  • Functional movement assessment: Grip Strength

    One day

  • Functional movement assessment: Timed up and go

    One day

  • Functional movement assessment: 10m walk test

    One day

  • +3 more secondary outcomes

Study Arms (2)

Sedentary

Predominantly engage in sedentary behaviours

Other: No intervention

Non-sedentary

Predominantly engage in non-sedentary behaviours

Other: No intervention

Interventions

No interventionOTHER
Non-sedentarySedentary

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sedentary and non-sedentary populations.

You may qualify if:

  • Male or female aged 30 - 60 years Individuals who are sedentary and do not participate in physical activities Individuals who participate in some physical activities Individuals who are highly active Must be free from injury or illness that will affects following typical weekly routines.

You may not qualify if:

  • Any medical condition that affects bone health, e.g. osteoporosis. Currently takes medication that affects bone health, e.g. long term steroid use.
  • Inability to participate in typical daily activity, e.g. severe arthritis, injury. Women who are post menopause Women who are on hormone replacement therapy Unable to participate in DXA scan, e.g. due to recent exposure to radiation, pregnancy status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wolverhampton

Walsall, West Midlands, WS1 3BD, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer in Biomechanics

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 10, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

GB(1)