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Register:	ISRCTN
Last refreshed on:	19 March 2018
Main ID:	ISRCTN16329455
Date of registration:	05/05/2016
Prospective Registration:	No
Primary sponsor:	University of Pécs
Public title:	Comparison of the direct effect of walking and resistant training
Scientific title:	Direct effects of physical training on markers of bone metabolism and serum sclerostin concentrations in older adults with low bone mass
Date of first enrolment:	01/11/2013
Target sample size:	150
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN16329455
Study type:	Interventional
Study design:	Three arm randomised controlled trial (Treatment)
Phase:

Countries of recruitment
Hungary

Contacts

Name:	Gabriella Császárné Gombos
Address:	University of Pécs Faculty of Health Sciences 8900 Zalaegerszeg Landorhegyi út 33 8900 Zalaegerszeg Hungary
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Low bone mass
Musculoskeletal Diseases
Low bone mass

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of Pécs

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	15/11/2015
URL:

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