Trial Outcomes & Findings for Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women. (NCT NCT03195517)
NCT ID: NCT03195517
Last Updated: 2019-02-11
Results Overview
P1NP is the most reliable serum marker of bone formation commercially available at the moment
COMPLETED
NA
33 participants
Baseline - Week 4
2019-02-11
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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33
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Overall Study
COMPLETED
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33
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.
Baseline characteristics by cohort
| Measure |
Control/Exercise Training
n=33 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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21 Participants
n=99 Participants
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Age, Categorical
>=65 years
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12 Participants
n=99 Participants
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Age, Customized
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62.6 years
STANDARD_DEVIATION 5.8 • n=99 Participants
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Sex/Gender, Customized
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33 Participants
n=99 Participants
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Sex: Female, Male
Female
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33 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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33 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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33 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
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Region of Enrollment
Italy
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33 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline - Week 4Population: 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)
P1NP is the most reliable serum marker of bone formation commercially available at the moment
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
P1NP, Baseline
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58.34 mcg/L
Standard Deviation 9.24
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Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
P1NP, W4
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57.91 mcg/L
Standard Deviation 8.49
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PRIMARY outcome
Timeframe: Week 4 - Week 12Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)
P1NP is the most reliable serum marker of bone formation, commercially available at the moment.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
P1NP, W4
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57.91 mcg/L
Standard Deviation 8.49
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Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
P1NP, W12
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64.87 mcg/L
Standard Deviation 12.67
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PRIMARY outcome
Timeframe: Baseline - W4Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)
Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Serum Sclerotin Levels
Sclerostin, Baseline
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36.76 pmol/L
Standard Deviation 9.68
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Serum Sclerotin Levels
Sclerostin, W4
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37.30 pmol/L
Standard Deviation 9.24
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PRIMARY outcome
Timeframe: Week 4 - Week 12Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS).
Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Sclerostin
Sclerostin, W4
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37.30 pmol/L
Standard Deviation 9.24
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Sclerostin
Sclerostin, W12
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33.96 pmol/L
Standard Deviation 7.29
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PRIMARY outcome
Timeframe: Baseline - Week 4Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
sCTX baseline
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0.52 ng/mL
Standard Deviation 0.13
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Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
sCTX, W4
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0.53 ng/mL
Standard Deviation 0.14
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PRIMARY outcome
Timeframe: Week 4 - Week 12Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
sCTX, W4
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0.53 ng/mL
Standard Deviation 0.14
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Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
sCTX, W12
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0.56 ng/mL
Standard Deviation 0.15
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PRIMARY outcome
Timeframe: Baseline - Week 4Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Circulating Osteoprogenitor Cells (OPCs)
OCN+/CD34+, W4
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1393.92 cells/ml
Standard Deviation 687.76
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Variation in Circulating Osteoprogenitor Cells (OPCs)
OCN+/CD34+ baseline
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1304.94 cells/ml
Standard Deviation 782.79
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Variation in Circulating Osteoprogenitor Cells (OPCs)
OCN+/AP+ baseline
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4485.21 cells/ml
Standard Deviation 1690.12
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Variation in Circulating Osteoprogenitor Cells (OPCs)
OCN+/AP+, W4
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4512.60 cells/ml
Standard Deviation 1658.76
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PRIMARY outcome
Timeframe: Week 4 - Week 12Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Circulating Osteoprogenitor Cells (OPCs).
OCN+/CD34+, W4
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1393.92 cells/ml
Standard Deviation 687.76
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Variation in Circulating Osteoprogenitor Cells (OPCs).
OCN+/CD34+, W12
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2311.82 cells/ml
Standard Deviation 1356.20
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Variation in Circulating Osteoprogenitor Cells (OPCs).
OCN+/AP+, W4
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4512.60 cells/ml
Standard Deviation 1658.76
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Variation in Circulating Osteoprogenitor Cells (OPCs).
OCN+/AP+, W12
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5062.00 cells/ml
Standard Deviation 1975.72
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SECONDARY outcome
Timeframe: Baseline - Week 4Health-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.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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Variation in Health-related Quality of Life (QoL)
Pain, Baseline
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22.59 score on a scale
Standard Deviation 17.67
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Variation in Health-related Quality of Life (QoL)
Pain, W4
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21.97 score on a scale
Standard Deviation 19.84
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Variation in Health-related Quality of Life (QoL)
Physical function, Baseline
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9.89 score on a scale
Standard Deviation 6.89
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Variation in Health-related Quality of Life (QoL)
Physica function, W4
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9.75 score on a scale
Standard Deviation 6.52
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Variation in Health-related Quality of Life (QoL)
Social function, Baseline
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24.38 score on a scale
Standard Deviation 11.75
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Variation in Health-related Quality of Life (QoL)
Social function, W4
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23.77 score on a scale
Standard Deviation 12.21
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Variation in Health-related Quality of Life (QoL)
General health perception, Baseline
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43.23 score on a scale
Standard Deviation 14.73
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Variation in Health-related Quality of Life (QoL)
General health perception, W4
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45.29 score on a scale
Standard Deviation 14.12
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Variation in Health-related Quality of Life (QoL)
Mental function, Baseline
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30.20 score on a scale
Standard Deviation 10.89
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Variation in Health-related Quality of Life (QoL)
Mental function, W4
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30.09 score on a scale
Standard Deviation 9.02
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Variation in Health-related Quality of Life (QoL)
Total score, Baseline
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20.51 score on a scale
Standard Deviation 7.06
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Variation in Health-related Quality of Life (QoL)
Total score, W4
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20.70 score on a scale
Standard Deviation 7.11
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SECONDARY outcome
Timeframe: Week 4 - Week 12Health-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.
Outcome measures
| Measure |
No Additional Physical Exercise
n=33 Participants
Usual recommendations for prevention of fractures in adults and elderly.
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|---|---|
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Variation in Health-related Quality of Life (QoL).
Pain, W4
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21.97 score on a scale
Standard Deviation 19.84
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Variation in Health-related Quality of Life (QoL).
Physical function, W4
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9.75 score on a scale
Standard Deviation 6.52
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Variation in Health-related Quality of Life (QoL).
Social function, W4
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23.77 score on a scale
Standard Deviation 12.21
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Variation in Health-related Quality of Life (QoL).
General health perception, W4
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45.29 score on a scale
Standard Deviation 14.12
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Variation in Health-related Quality of Life (QoL).
Mental function, W4
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30.09 score on a scale
Standard Deviation 9.02
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Variation in Health-related Quality of Life (QoL).
Total score, W4
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20.70 score on a scale
Standard Deviation 7.11
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Variation in Health-related Quality of Life (QoL).
Pain, W12
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13.36 score on a scale
Standard Deviation 12.45
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Variation in Health-related Quality of Life (QoL).
Physical function, W12
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8.13 score on a scale
Standard Deviation 6.22
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Variation in Health-related Quality of Life (QoL).
Social function, W12
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22.10 score on a scale
Standard Deviation 12.88
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Variation in Health-related Quality of Life (QoL).
General health perception, W12
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41.66 score on a scale
Standard Deviation 14.47
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Variation in Health-related Quality of Life (QoL).
Mental function, W12
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28.55 score on a scale
Standard Deviation 10.25
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Variation in Health-related Quality of Life (QoL).
Total score, W12
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18.55 score on a scale
Standard Deviation 7.02
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Adverse Events
Control/Exercise Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place