Condition category
Musculoskeletal Diseases
Date applied
15/04/2016
Date assigned
05/05/2016
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Low bone mass, also known as osteopenia, is a condition in which a person’s bones are less dense than average. In some cases, it can lead to further bone loss and a condition called osteoporosis. Osteoporosis is a long term condition, which gets progressively worse, which makes bone weak, brittle and more likely to break. This deterioration can weaken the bones so much that person with low bone mass can suffer a fracture during everyday activities, such as lifting a bag of groceries. There is a great deal of evidence that weight-bearing and resistance exercises support the development of strong bones because the strain put on bones causes them to become more dense (osteogenic). The aim of this study is to compare the effects of a single session of resistance exercise or walking on the chemical indicators (biomarkers) of bone metabolism (breakdown) in people with low bone mass.

Who can participate?
Women with osteoporosis/osteopenia

What does the study involve?
Participants re randomly allocated to one of three groups. Those in the first group take part in a single session of resistance training, which lasts for around 46 minutes. This involves a series of exercises that use large muscle groups and major joints to strengthen muscles. Those in the second group take part in a single session involving moderate intensity brisk walking outdoors on even ground. Participants maintain their pace by keeping to a rhythm of 100 steps per minute for around 46 minutes. Those in the third group do not take part in any exercises. At the start of the study and then again within 5 minutes of completing the exercises, all participants have a sample of blood taken so that indicators of bone metabolism can be measured. Additionally, at the start of the study, participants have their bone mineral density measured using a type of x-ray.

What are the possible benefits and risks of participating?
Participants benefit from receiving information about their bone mineral density. There is a small risk of bruising or discomfort during and after blood tests.

Where is the study run from?
Zala County Hospital (Hungary)

When is the study starting and how long is it expected to run for?
November 2013 to November 2015

Who is funding the study?
University of Pécs (Hungary)

Who is the main contact?
Mrs Gabriella Császárné Gombos

Trial website

Contact information

Type

Public

Primary contact

Mrs Gabriella Császárné Gombos

ORCID ID

Contact details

University of Pécs
Faculty of Health Sciences
8900 Zalaegerszeg
Landorhegyi út 33
Zalaegerszeg
8900
Hungary

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Direct effects of physical training on markers of bone metabolism and serum sclerostin concentrations in older adults with low bone mass

Acronym

Study hypothesis

The aim of this study is to examine the direct effects of a single session of resistance exercise or walking on biochemical markers of bone metabolism in participants with low bone mass.

Ethics approval

1. Regional Committee of Science and Research Ethics, 24/11/2011, ref: 46/2011
2. Policy Administration Service of Public Health of Zala County, 09/03/2015, ref: ZAR/097/194-8/2015

Study design

Three arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Low bone mass

Intervention

The participants were randomly assigned to a resistance exercise group (RG; n = 50), walking group (WG; n = 50), or control group (CG; n = 50).

Resistance exercise group: Participants take part in a single resistance training exercise session. This involves 8 minutes of dynamic warm-up consisting of exercises requiring movements of large muscle groups and major joints that incorporated small impacts with the ground, approximately 30 minutes of exercises that include muscle-strengthening and core stabilization elements, and an 8 minute cool down consisting of walking and static and dynamic stretches was performed.

Walking group: Participants take part in a single session involving moderate intensity brisk walking to a rhythm (100 steps/min) provided by a metronome, continuously for 46 minutes outdoors on even ground.

Control group: Participants continue as normal and do not receive any interventions.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Bone-specific alkaline phosphatase (BALP) concentration is measured using a photometric assay at baseline and immediately after the intervention
2. Carboxy-terminal cross-linked telopeptide of type I collagen (CTX) concentration is measured using an electrochemiluminescence immunoassay (ECLIA) at baseline and immediately after the intervention
3. Serum sclerostin concentration is measured using a qualitative sandwich enzyme-linked immunosorbent assay (ELISA) at baseline and immediately after the intervention

Several assistants performed sample collection simultaneously to ensure rapid collection within 0 –5 minutes after the exercise sessions.

Secondary outcome measures

Bone mineral density (BMD) is determined by dual energy X-ray absorptiometry (DEXA) using a LUNAR DPX densitometer at baseline.

Overall trial start date

01/11/2013

Overall trial end date

15/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Aged between 35 and 65 years
3. New diagnosis of osteoporosis/osteopenia
4. Lack of endocrine or metabolic disease which would have an impact on bone mineral density or musculoskeletal system
5. Normal lifestyle and activity
6. Agreement to participate
7. Generally considered to be healthy

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

150 female subjects

Participant exclusion criteria

1. Any condition influencing calcium and bone metabolism (except dietary calcium and Vitamin D supplementation),
2. Ongoing hormone replacement therapy
3. Any known endocrine/metabolic, renal, or hepatic disease (e.g., hypogonadism, hyperthyroidism, hyperparathyroidism, or increased glucocorticoid levels)
4. Any physical injury (orthopedic, rheumatologic) hindering the performance of physical activity
5. Osseous fracture of any origin during the previous 6 months
6. A diagnosis of cardiovascular disease or uncontrolled hypertension
7. Any non-antibiotic medication within the past year, including steroids of any type, thyroid hormones, diuretics, or anticoagulants
8. Any antibiotic use within the last 6 months

Recruitment start date

01/11/2013

Recruitment end date

15/03/2014

Locations

Countries of recruitment

Hungary

Trial participating centre

Zala County Hospital (Zala Megyei Kórház)
Zalaegerszeg Zrínyi Miklós u. 1
Zala
8900
Hungary

Sponsor information

Organisation

University of Pécs

Sponsor details

Faculty of Health Sciences
Vörösmarty 4
Pécs
7621
Hungary

Sponsor type

University/education

Website

www.etk.pte.hu

Funders

Funder type

University/education

Funder name

University of Pécs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the journal BMC Musculoskeletal Disorders.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes