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Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

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ClinicalTrials.gov Identifier: NCT03195517
Recruitment Status : Completed
First Posted : June 22, 2017
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Rita Lombardini, University Of Perugia

Brief Summary:
The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.

Condition or disease Intervention/treatment Phase
Osteopenia Bone Turnover Markers Quality of Life Other: Physical exercise Not Applicable

Detailed Description:
Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders" Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33 post-menopausal women volunteered to participate in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This was an interventional, single group assignment study in which the subjects were first assigned to the control group and, after 1-month interval with no physical training, were shifted into the 3-months exercise intervention group. Thus, the subjects acted as their own control at the end of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a 3-month Weight-bearing and Resistance Exercise Training on Circulating Osteoprogenitor Cells and Bone Formation Markers in Postmenopausal Women With Low Bone Mass.
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Exercise

The exercise program was performed at C.U.R.I.A.Mo. Institute of "Università degli Studi di Perugia". Twenty-four exercise sessions were provided, carried out twice a week for three months. Each session was supervised by two graduated trainers and two medical doctors with a maximum attendance of 5 patient/group.

Each session lasted 45 minutes divided into 15 minutes of aerobic activity and 30 minutes of weight-bearing and resistance activities.

This latter section was specifically projected for adults and older adults with increased risk of fractures and was intended to improve muscle strength and flexibility, balance and, as a result, to prevent the risk of falls.

Other: Physical exercise
No Intervention: No additional physical exercise
Usual recommendations for prevention of fractures in adults and elderly.



Primary Outcome Measures :
  1. Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) [ Time Frame: Baseline - Week 4 ]
    P1NP is the most reliable serum marker of bone formation commercially available at the moment

  2. Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). [ Time Frame: Week 4 - Week 12 ]
    P1NP is the most reliable serum marker of bone formation, commercially available at the moment.

  3. Serum Sclerotin Levels [ Time Frame: Baseline - W4 ]
    Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.

  4. Sclerostin [ Time Frame: Week 4 - Week 12 ]
    Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.

  5. Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) [ Time Frame: Baseline - Week 4 ]
    Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation

  6. Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) [ Time Frame: Week 4 - Week 12 ]
    Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.

  7. Variation in Circulating Osteoprogenitor Cells (OPCs) [ Time Frame: Baseline - Week 4 ]
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).

  8. Variation in Circulating Osteoprogenitor Cells (OPCs). [ Time Frame: Week 4 - Week 12 ]
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).


Secondary Outcome Measures :
  1. Variation in Health-related Quality of Life (QoL) [ Time Frame: Baseline - Week 4 ]
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.

  2. Variation in Health-related Quality of Life (QoL). [ Time Frame: Week 4 - Week 12 ]
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.



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Ages Eligible for Study:   52 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • postmenopausal
  • bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
  • be able to attend an exercise program 2 times per week over the 3-month period
  • stated availability throughout the entire study period

Exclusion Criteria:

  • secondary causes of bone loss such as osteomalacia, glucocorticoid medication
  • co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
  • physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
  • a past vertebral fracture
  • history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases
  • current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195517


Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Lombardini University of Perugia, Italy

Publications:
Lips P, Leplege A (2000). Development and validation of quality of life questionnaire for patients with vertebral fractures: Qualeffo-41. Quality of Life Research 9(6a):763-766.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rita Lombardini, Principal Investigator, University Of Perugia
ClinicalTrials.gov Identifier: NCT03195517     History of Changes
Other Study ID Numbers: OPCuriamo-1
First Posted: June 22, 2017    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019
Last Verified: September 2018
Keywords provided by Rita Lombardini, University Of Perugia:
Osteopenia
Physical activity
Bone turnover markers
Osteoprogenitor cells
Quality of life
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases