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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise | Experimental | 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. |
|
| No additional physical exercise | No Intervention | Usual recommendations for prevention of fractures in adults and elderly. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) | P1NP is the most reliable serum marker of bone formation commercially available at the moment | Baseline - Week 4 |
| Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). | P1NP is the most reliable serum marker of bone formation, commercially available at the moment. | Week 4 - Week 12 |
| Serum Sclerotin Levels | Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism. | Baseline - W4 |
| Sclerostin | Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism. | Week 4 - Week 12 |
| Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) | 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 | Baseline - Week 4 |
| Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) | 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. | Week 4 - Week 12 |
| Variation in Circulating Osteoprogenitor Cells (OPCs) |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Health-related Quality of Life (QoL) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lombardini | University Of Perugia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15984409 | Background | Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318. | |
| 27244129 | Background | Pasqualini L, Leli C, Ministrini S, Schillaci G, Zappavigna RM, Lombardini R, Scarponi AM, Mannarino E. Relationships between global physical activity and bone mineral density in a group of male and female students. J Sports Med Phys Fitness. 2017 Mar;57(3):238-243. doi: 10.23736/S0022-4707.16.06054-0. Epub 2016 May 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control/Exercise Training | At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control/Exercise Training | 33 osteopenic postmenopausal women were included in the study. Bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment, after 1 month run-in and after 3 months of high-impact exercise training. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) | P1NP is the most reliable serum marker of bone formation commercially available at the moment | Post-menopausal women with low bone mass at dual energy X-ray absorptiometry (DEXA) measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS) | Posted | Mean | Standard Deviation | mcg/L | Baseline - Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control/Exercise Training | At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training. |
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Short duration of the observation (12 weeks). Small number of the sample. We did not provide any confirmation of the effects of the exercise program in terms of bone mineral density (BMD) or fracture risk.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rita Lombardini | University of Perugia - Italy | +39 075 578 4027 | rita.lombardini@unipg.it |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
| Baseline - Week 4 |
| Variation in Circulating Osteoprogenitor Cells (OPCs). | Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +). | Week 4 - Week 12 |
| Baseline - Week 4 |
| Variation in Health-related Quality of Life (QoL). | 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. | Week 4 - Week 12 |
| 18981037 | Background | Martyn-St James M, Carroll S. A meta-analysis of impact exercise on postmenopausal bone loss: the case for mixed loading exercise programmes. Br J Sports Med. 2009 Dec;43(12):898-908. doi: 10.1136/bjsm.2008.052704. Epub 2008 Nov 3. |
| 18089564 | Background | Robling AG, Niziolek PJ, Baldridge LA, Condon KW, Allen MR, Alam I, Mantila SM, Gluhak-Heinrich J, Bellido TM, Harris SE, Turner CH. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 Feb 29;283(9):5866-75. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17. |
| 19717503 | Background | Li WC, Chen YC, Yang RS, Tsauo JY. Effects of exercise programmes on quality of life in osteoporotic and osteopenic postmenopausal women: a systematic review and meta-analysis. Clin Rehabil. 2009 Oct;23(10):888-96. doi: 10.1177/0269215509339002. Epub 2009 Aug 28. |
| 19484167 | Background | Pirro M, Leli C, Fabbriciani G, Manfredelli MR, Callarelli L, Bagaglia F, Scarponi AM, Mannarino E. Association between circulating osteoprogenitor cell numbers and bone mineral density in postmenopausal osteoporosis. Osteoporos Int. 2010 Feb;21(2):297-306. doi: 10.1007/s00198-009-0968-0. Epub 2009 May 30. |
| Background | 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. |
| 18949504 | Background | Adami S, Gatti D, Viapiana O, Fiore CE, Nuti R, Luisetto G, Ponte M, Rossini M; BONTURNO Study Group. Physical activity and bone turnover markers: a cross-sectional and a longitudinal study. Calcif Tissue Int. 2008 Dec;83(6):388-92. doi: 10.1007/s00223-008-9184-8. Epub 2008 Oct 24. |
| 30809725 | Derived | Pasqualini L, Ministrini S, Lombardini R, Bagaglia F, Paltriccia R, Pippi R, Collebrusco L, Reginato E, Sbroma Tomaro E, Marini E, D'Abbondanza M, Scarponi AM, De Feo P, Pirro M. Effects of a 3-month weight-bearing and resistance exercise training on circulating osteogenic cells and bone formation markers in postmenopausal women with low bone mass. Osteoporos Int. 2019 Apr;30(4):797-806. doi: 10.1007/s00198-019-04908-9. Epub 2019 Feb 26. |
| Participants |
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| Age, Customized | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). | P1NP is the most reliable serum marker of bone formation, commercially available at the moment. | Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS) | Posted | Mean | Standard Deviation | mcg/L | Week 4 - Week 12 |
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| Primary | Serum Sclerotin Levels | Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism. | Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS) | Posted | Mean | Standard Deviation | pmol/L | Baseline - W4 |
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| Primary | Sclerostin | Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism. | Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS). | Posted | Mean | Standard Deviation | pmol/L | Week 4 - Week 12 |
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| Primary | Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) | 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 | Posted | Mean | Standard Deviation | ng/mL | Baseline - Week 4 |
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| Primary | Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) | 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. | Posted | Mean | Standard Deviation | ng/mL | Week 4 - Week 12 |
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| Primary | Variation in Circulating Osteoprogenitor Cells (OPCs) | Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +). | Posted | Mean | Standard Deviation | cells/ml | Baseline - Week 4 |
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| Primary | Variation in Circulating Osteoprogenitor Cells (OPCs). | Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +). | Posted | Mean | Standard Deviation | cells/ml | Week 4 - Week 12 |
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| Secondary | Variation in Health-related Quality of Life (QoL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 4 |
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| Secondary | Variation in Health-related Quality of Life (QoL). | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 12 |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
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| D001519 | Behavior |
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| OCN+/AP+, W4 |
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| Title | Measurements |
|---|---|
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| OCN+/AP+, W12 |
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| Title | Measurements |
|---|---|
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| Physica function, W4 |
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| Social function, Baseline |
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| Social function, W4 |
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| General health perception, Baseline |
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| General health perception, W4 |
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| Mental function, Baseline |
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| Mental function, W4 |
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| Total score, Baseline |
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| Total score, W4 |
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| Title | Measurements |
|---|---|
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| General health perception, W4 |
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| Mental function, W4 |
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| Total score, W4 |
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| Pain, W12 |
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| Physical function, W12 |
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| Social function, W12 |
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| General health perception, W12 |
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| Mental function, W12 |
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| Total score, W12 |
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