Bone HealthNCT02928913
The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health
An observational study of Bone Health, run by Dr Tina Smith at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Jul 2017
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sedentary and non-sedentary populations.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Wolverhampton
Walsall, West Midlands, WS1 3BD
About this study
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.
Read the detailed description
Significant proportions of adults engage in sedentary behaviour for prolonged periods of time which is generally regarded as having deleterious effects on health. However, far less is known about its specific effects on bone health. Exercise has been proposed as a method of improving bone health, as impact forces generated as the foot contacts the ground during physical activity have the potential to aid bone maintenance and development.
The properties of bone are regulated through the amount mechanical loading, frequency of loading and duration of loading endured, which can create an osteogenic effect. These variables can be quantified via accelerometry which records the magnitude, rate and duration of accelerations experienced at the site on the body where the accelerometer is worn. Although there is a vast amount of literature where accelerometers have been used to monitor physical activity, there is a lack of studies that use accelerometers to determine the most effective exercise for bone, especially in relation to the lumbar spine. Exploring the bone health and loading characteristics of sedentary and low and highly active non-sedentary individuals will provide evidence upon which to base future interventions that are likely to be of benefit for bone health in sedentary populations.
- Conditions
- Bone Health
- Being tested
- No intervention
- Keywords
- sedentary, non-sedentary, populations
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Predominantly engage in sedentary behaviours Receives: Other: No intervention | |
| Non-sedentary | Predominantly engage in non-sedentary behaviours Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: One day
Secondary outcomes (8)
Mechanical loading dose during daily activity via accelerometry
Measured: 7 days
Mechanical loading intensity during daily activity via accelerometry
Measured: 7 days
Functional movement assessment: Grip Strength
Measured: One day
Functional movement assessment: Timed up and go
Measured: One day
Functional movement assessment: 10m walk test
Measured: One day
Functional movement assessment: 5 times sit to stand
Measured: One day
Functional movement assessment: gait analysis (acceleration at hip and lumbar spine)
Measured: One day
Functional movement assessment: gait analysis (ground reaction force)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Tina Smith
- Sponsor type
- University, hospital or other
- Collaborators
- London South Bank University
- Responsible party
- Sponsor-investigator, Dr Tina Smith, University of Wolverhampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928913
- Sponsor's protocol ID
- 01/0416/TS/UOW
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health
- ClinicalTrials.gov ID
- NCT02928913
- Acronym / sponsor ID
- 01/0416/TS/UOW
- Conditions
- Bone Health
- Keywords
- sedentary, non-sedentary, populations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dr Tina SmithUniversity, hospital or other
- Collaborators
- London South Bank University
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Oct 2016 (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.
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.
Detailed description
Significant proportions of adults engage in sedentary behaviour for prolonged periods of time which is generally regarded as having deleterious effects on health. However, far less is known about its specific effects on bone health. Exercise has been proposed as a method of improving bone health, as impact forces generated as the foot contacts the ground during physical activity have the potential to aid bone maintenance and development.
The properties of bone are regulated through the amount mechanical loading, frequency of loading and duration of loading endured, which can create an osteogenic effect. These variables can be quantified via accelerometry which records the magnitude, rate and duration of accelerations experienced at the site on the body where the accelerometer is worn. Although there is a vast amount of literature where accelerometers have been used to monitor physical activity, there is a lack of studies that use accelerometers to determine the most effective exercise for bone, especially in relation to the lumbar spine. Exploring the bone health and loading characteristics of sedentary and low and highly active non-sedentary individuals will provide evidence upon which to base future interventions that are likely to be of benefit for bone health in sedentary populations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary | – | Other: No interventionPredominantly engage in sedentary behaviours |
| Non-sedentary | – | Other: No interventionPredominantly engage in non-sedentary behaviours |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sedentary and non-sedentary populations.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Non-sedentary, Sedentary |
Primary outcome
Bone mineral density
Time frame: One day
8 secondary outcomes
Mechanical loading dose during daily activity via accelerometry
Time frame: 7 days
Mechanical loading intensity during daily activity via accelerometry
Time frame: 7 days
Functional movement assessment: Grip Strength
Time frame: One day
Functional movement assessment: Timed up and go
Time frame: One day
Functional movement assessment: 10m walk test
Time frame: One day
Functional movement assessment: 5 times sit to stand
Time frame: One day
Functional movement assessment: gait analysis (acceleration at hip and lumbar spine)
Time frame: One day
Functional movement assessment: gait analysis (ground reaction force)
Time frame: One day
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 26 Oct 2017.
Related trials for Bone Health
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
RecruitingPhase 3
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Neurodevelopment Outcome, Linear Growth
Not yet recruiting
Calcium-Rich Food Versus Calcium Carbonate for Bone Health
Osteopenia, Osteoporosis
Not yet recruiting
Early Time-Restricted Eating Combined With Exercise in Older Adults
Nutrition, Health and Wellbeing
RecruitingObservational study
Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study
Osteoporosis, Musculoskeletal Health
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bone Health, run by Dr Tina Smith 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 1 inclusion and 2 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 26 Oct 2017. 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?
Bone mineral density (time frame: One day). 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 26 Oct 2017; AzTrials last refreshed its copy on 1 Nov 2026.