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Trial record 1 of 1 for:    NCT 00729378
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Jump-In: Building Better Bones

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ClinicalTrials.gov Identifier: NCT00729378
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Going, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Adolescent Development
Intervention: Other: Skeletal loading

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was performed for three years (2007-2009) in a total of 16 elementary and middle schools (9 intervention and 7 control) in two Tucson, Arizona area school districts. Recruitment consisted of attending back to school days and holding recruitment assemblies before or after school.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Intervention and control schools designated prior to recruiting. Schools were selected based on size, demographics, and student flow from elementary to middle school to prevent contamination. 739 participants completed informed consent process (agreed to participate); only 509 scheduled measurement appointments and completed study measurements.

Reporting Groups
  Description
Exercise Intervention

Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.

Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).

Control Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).

Participant Flow for 4 periods

Period 1:   Baseline
    Exercise Intervention   Control
STARTED   430   309 
COMPLETED   292   217 
NOT COMPLETED   138   92 
Did not complete study measurements                72                33 
Withdrawal by Subject                66                59 

Period 2:   12-months
    Exercise Intervention   Control
STARTED   292   217 
COMPLETED   192   152 
NOT COMPLETED   100   65 
Lost to Follow-up                100                65 

Period 3:   24-months
    Exercise Intervention   Control
STARTED   192   152 
COMPLETED   120   101 
NOT COMPLETED   72   51 
Lost to Follow-up                72                51 

Period 4:   36-months
    Exercise Intervention   Control
STARTED   120   101 
COMPLETED   105   95 
NOT COMPLETED   15   6 
Lost to Follow-up                15                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exercise Intervention

Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.

Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).

Control Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
Total Total of all reporting groups

Baseline Measures
   Exercise Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 292   217   509 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.6  (1.1)   10.7  (1.0)   10.7  (1.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      292 100.0%      217 100.0%      509 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      67  22.9%      50  23.0%      117  23.0% 
Not Hispanic or Latino      225  77.1%      167  77.0%      392  77.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.3%      2   0.9%      3   0.6% 
Asian      20   6.8%      11   5.1%      31   6.1% 
Native Hawaiian or Other Pacific Islander      2   0.7%      1   0.5%      3   0.6% 
Black or African American      11   3.8%      3   1.4%      14   2.8% 
White      254  87.0%      196  90.3%      450  88.4% 
More than one race      2   0.7%      0   0.0%      2   0.4% 
Unknown or Not Reported      2   0.7%      4   1.8%      6   1.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   292   217   509 


  Outcome Measures

1.  Primary:   Baseline Total Volumetric Bone Density at the Femur 4% Site   [ Time Frame: Baseline ]

2.  Primary:   Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site   [ Time Frame: Baseline ]

3.  Primary:   Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site   [ Time Frame: Baseline ]

4.  Primary:   Baseline Trabecular Bone Area at the Femur 4% Site   [ Time Frame: Baseline ]

5.  Primary:   Baseline Cortical Bone Area at the Femur 4% Site   [ Time Frame: Baseline ]

6.  Primary:   Baseline Periosteal Circumference at the Femur 4% Site   [ Time Frame: Baseline ]

7.  Primary:   Baseline Bone Strength Index at the Femur 4% Site   [ Time Frame: Baseline ]

8.  Primary:   Baseline Total Volumetric Bone Density at the Femur 20% Site   [ Time Frame: Baseline ]

9.  Primary:   Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site   [ Time Frame: Baseline ]

10.  Primary:   Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site   [ Time Frame: Baseline ]

11.  Primary:   Baseline Periosteal Circumference at the Femur 20% Site   [ Time Frame: Baseline ]

12.  Primary:   Baseline Cortical Thickness at the Femur 20% Site   [ Time Frame: Baseline ]

13.  Primary:   Baseline Stress-Strain Index at the Femur 20% Site   [ Time Frame: Baseline ]

14.  Primary:   Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site   [ Time Frame: Baseline ]

15.  Primary:   Baseline Total Volumetric Bone Density at the Tibia 4% Site   [ Time Frame: Baseline ]

16.  Primary:   Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site   [ Time Frame: Baseline ]

17.  Primary:   Baseline Trabecular Bone Area at the Tibia 4% Site   [ Time Frame: Baseline ]

18.  Primary:   Baseline Cortical Bone Area at the Tibia 4% Site   [ Time Frame: Baseline ]

19.  Primary:   Baseline Periosteal Circumference at the Tibia 4% Site   [ Time Frame: Baseline ]

20.  Primary:   Baseline Bone Strength Index at the Tibia 4% Site   [ Time Frame: Baseline ]

21.  Primary:   Baseline Total Volumetric Bone Density at the Tibia 50% Site   [ Time Frame: Baseline ]

22.  Primary:   Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site   [ Time Frame: Baseline ]

23.  Primary:   Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site   [ Time Frame: Baseline ]

24.  Primary:   Baseline Periosteal Circumference at the Tibia 50% Site   [ Time Frame: Baseline ]

25.  Primary:   Baseline Cortical Thickness at the Tibia 50% Site   [ Time Frame: Baseline ]

26.  Primary:   Baseline Stress-Strain Index at the Tibia 50% Site   [ Time Frame: Baseline ]

27.  Primary:   Baseline Total Volumetric Bone Density at the Tibia 66% Site   [ Time Frame: Baseline ]

28.  Primary:   Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site   [ Time Frame: Baseline ]

29.  Primary:   Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site   [ Time Frame: Baseline ]

30.  Primary:   Baseline Periosteal Circumference at the Tibia 66% Site   [ Time Frame: Baseline ]

31.  Primary:   Baseline Cortical Thickness at the Tibia 66% Site   [ Time Frame: Baseline ]

32.  Primary:   Baseline Stress-Strain Index at the Tibia 66% Site   [ Time Frame: Baseline ]

33.  Primary:   12-month Change in Total Volumetric Bone Density the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

34.  Primary:   12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

35.  Primary:   12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

36.  Primary:   12-month Change in Trabecular Bone Area at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

37.  Primary:   12-month Change in Cortical Bone Area at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

38.  Primary:   12-month Change in Periosteal Circumference at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

39.  Primary:   12-month Change in Bone Strength Index at the Femur 4% Site   [ Time Frame: Baseline to 12-months ]

40.  Primary:   12-month Change in Total Volumetric Bone Density at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

41.  Primary:   12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

42.  Primary:   12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

43.  Primary:   12-month Change in Thickness of Cortical Bone at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

44.  Primary:   12-month Change in Periosteal Circumference at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

45.  Primary:   12-month Change in Stress-Strain Index at the Femur 20% Site   [ Time Frame: Baseline to 12-months ]

46.  Primary:   12-month Change in Total Volumetric Bone Density at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

47.  Primary:   12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

48.  Primary:   12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

49.  Primary:   12-month Change in Trabecular Bone Area at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

50.  Primary:   12-month Change in Cortical Bone Area at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

51.  Primary:   12-month Change in Periosteal Circumference at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

52.  Primary:   12-month Change in Bone Strength Index at the Tibia 4% Site   [ Time Frame: Baseline to 12-months ]

53.  Primary:   12-month Change in Total Volumetric Bone Density at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

54.  Primary:   12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

55.  Primary:   12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

56.  Primary:   12-month Change in Periosteal Circumference at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

57.  Primary:   12-month Change in Cortical Thickness at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

58.  Primary:   12-month Change in Stress-Strain Index at the Tibia 50% Site   [ Time Frame: Baseline to 12-months ]

59.  Primary:   12-month Change in Total Volumetric Bone Density at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

60.  Primary:   12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

61.  Primary:   12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

62.  Primary:   12-month Change in Periosteal Circumference at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

63.  Primary:   12-month Change in Cortical Thickness at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

64.  Primary:   12-month Change in Stress-Strain Index at the Tibia 66% Site   [ Time Frame: Baseline to 12-months ]

65.  Primary:   24-month in Change in Total Volumetric Bone Density the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

66.  Primary:   24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

67.  Primary:   24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

68.  Primary:   24-month Change in Trabecular Bone Area at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

69.  Primary:   24-month Change in Cortical Bone Area at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

70.  Primary:   24-month Change in Periosteal Circumference at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

71.  Primary:   24-month Change in Bone Strength Index at the Femur 4% Site   [ Time Frame: Baseline to 24-months ]

72.  Primary:   24-month Change in Total Volumetric Bone Density at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

73.  Primary:   24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

74.  Primary:   24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

75.  Primary:   24-month Change in Thickness of Cortical Bone at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

76.  Primary:   24-month Change in Periosteal Circumference at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

77.  Primary:   24-month Change in Stress-Strain Index at the Femur 20% Site   [ Time Frame: Baseline to 24-months ]

78.  Primary:   24-month Change in Total Volumetric Bone Density at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

79.  Primary:   24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

80.  Primary:   24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

81.  Primary:   24-month Change in Trabecular Bone Area at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

82.  Primary:   24-month Change in Cortical Bone Area at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

83.  Primary:   24-month Change in Periosteal Circumference at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

84.  Primary:   24-month Change in Bone Strength Index at the Tibia 4% Site   [ Time Frame: Baseline to 24-months ]

85.  Primary:   24-month Change in Total Volumetric Bone Density at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

86.  Primary:   24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

87.  Primary:   24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

88.  Primary:   24-month Change in Periosteal Circumference at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

89.  Primary:   24-month Change in Cortical Thickness at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

90.  Primary:   24-month Change in Stress-Strain Index at the Tibia 50% Site   [ Time Frame: Baseline to 24-months ]

91.  Primary:   24-month Change in Total Volumetric Bone Density at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]

92.  Primary:   24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]

93.  Primary:   24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]

94.  Primary:   24-month Change in Periosteal Circumference at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]

95.  Primary:   24-month Change in Cortical Thickness at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]

96.  Primary:   24-month Change in Stress-Strain Index at the Tibia 66% Site   [ Time Frame: Baseline to 24-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Scott Going, Ph.D.
Organization: University of Arizona
phone: 520-626-3432
e-mail: going@u.arizona.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scott Going, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00729378     History of Changes
Other Study ID Numbers: HD050775
First Submitted: August 5, 2008
First Posted: August 7, 2008
Results First Submitted: April 24, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017