- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05292261
Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women (H4HW)
Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport.
The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Porto
-
Maia, Porto, Portugal, 4476-690
- University of Maia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years
Exclusion Criteria:
- Any medical contraindications to perform moderate-to-vigorous physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Team handball group
The team handball group participants were encouraged to performed at least two out of three weekly supervised team handball training sessions of 60 min each, for 36 weeks.
|
Two to three weekly sessions of recreational team handball training for 36 weeks.
Each 60-min session started with a standardised warm-up (including running, coordination, strength, flexibility, and balance exercises) followed by three 15-min periods of recreational team handball matches, interspersed by 2-min breaks, played as small-sided games (4v4, 5v5 or 6v6).
The training sessions were performed on an indoor team handball court (40x20 m) adjusted to result in 34-36 m2 per player.
During the matches, the participants rotated positions every 3 min in a random order, including the goalkeeper and no exclusions or substitutions were applied.
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No Intervention: Control group
The control group participants were instructed to keep their regular daily physical activity for 36 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between group differences in peak oxygen uptake at week 16
Time Frame: Week 16
|
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
|
Week 16
|
Between group differences in peak oxygen uptake at week 36
Time Frame: Week 36
|
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
|
Week 36
|
Changes from baseline in peak oxygen uptake at week 16
Time Frame: Baseline and week 16
|
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
|
Baseline and week 16
|
Changes from baseline in peak oxygen uptake at week 36
Time Frame: Baseline and week 36
|
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
|
Baseline and week 36
|
Changes from week 16 in peak oxygen uptake at week 36
Time Frame: Week 16 and week 36
|
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
|
Week 16 and week 36
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between group differences in resting heart rate at week 16
Time Frame: Week 16
|
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
|
Week 16
|
Between group differences in resting heart rate at week 36
Time Frame: Week 36
|
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
|
Week 36
|
Changes from baseline in resting heart rate at week 16
Time Frame: Baseline and week 16
|
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
|
Baseline and week 16
|
Changes from baseline in resting heart rate at week 36
Time Frame: Baseline and week 36
|
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
|
Baseline and week 36
|
Changes from week 16 in resting heart rate at week 36
Time Frame: Week 16 and week 36
|
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
|
Week 16 and week 36
|
Between group differences in body mass at week 16
Time Frame: Week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16
|
Between group differences in body mass at week 36
Time Frame: Week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 36
|
Changes from baseline in body mass at week 16
Time Frame: Baseline and week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 16
|
Changes from baseline in body mass at week 36
Time Frame: Baseline and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in body mass at week 36
Time Frame: Week 16 and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16 and week 36
|
Between group differences in fat mass at week 16
Time Frame: Week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16
|
Between group differences in fat mass at week 36
Time Frame: Week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 36
|
Changes from baseline in fat mass at week 16
Time Frame: Baseline and week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 16
|
Changes from baseline in fat mass at week 36
Time Frame: Baseline and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in fat mass at week 36
Time Frame: Week 16 and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16 and week 36
|
Between group differences in lean mass at week 16
Time Frame: Week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16
|
Between group differences in lean mass at week 36
Time Frame: Week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 36
|
Changes from baseline in lean mass at week 16
Time Frame: Baseline and week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 16
|
Changes from baseline in lean mass at week 36
Time Frame: Baseline and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in lean mass at week 36
Time Frame: Week 16 and week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16 and week 36
|
Between group differences in lumbar spine bone mineral density at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in lumbar spine bone mineral density at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in lumbar spine bone mineral density at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in lumbar spine bone mineral density at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in lumbar spine bone mineral density at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in dominant femur bone mineral density at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in dominant femur bone mineral density at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in dominant femur bone mineral density at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in dominant femur bone mineral density at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in dominant femur bone mineral density at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in dominant femoral neck bone mineral density at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in dominant femoral neck bone mineral density at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in dominant femoral neck bone mineral density at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in dominant femoral neck bone mineral density at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in dominant femoral neck bone mineral density at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in lumbar spine bone mineral content at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in lumbar spine bone mineral content at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in lumbar spine bone mineral content at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in lumbar spine bone mineral content at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in lumbar spine bone mineral content at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in dominant femur bone mineral content at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in dominant femur bone mineral content at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in dominant femur bone mineral content at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in dominant femur bone mineral content at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in dominant femur bone mineral content at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in dominant femoral neck bone mineral content at week 16
Time Frame: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
|
Between group differences in dominant femoral neck bone mineral content at week 36
Time Frame: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
Changes from baseline in dominant femoral neck bone mineral content at week 16
Time Frame: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 16
|
Changes from baseline in dominant femoral neck bone mineral content at week 36
Time Frame: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
Changes from week 16 in dominant femoral neck bone mineral content at week 36
Time Frame: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
Between group differences in osteocalcin at week 16
Time Frame: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
|
Between group differences in osteocalcin at week 36
Time Frame: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
Changes from baseline in osteocalcin at week 16
Time Frame: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
|
Changes from baseline in osteocalcin at week 36
Time Frame: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
|
Changes from week 16 in osteocalcin at week 36
Time Frame: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
|
Between group differences in procollagen type-1 amino-terminal propeptide at week 16
Time Frame: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
|
Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Time Frame: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16
Time Frame: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
|
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Time Frame: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
|
Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
Time Frame: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
|
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
Time Frame: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
|
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Time Frame: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
Time Frame: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
|
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Time Frame: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
|
Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
Time Frame: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
|
Between group differences in sclerostin at week 16
Time Frame: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
|
Between group differences in sclerostin at week 36
Time Frame: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
Changes from baseline in sclerostin at week 16
Time Frame: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
|
Changes from baseline in sclerostin at week 36
Time Frame: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
|
Changes from week 16 in sclerostin at week 36
Time Frame: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
|
Between group differences in isometric knee extension peak torque at week 16
Time Frame: Week 16
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16
|
Between group differences in isometric knee extension peak torque at week 36
Time Frame: Week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
|
Changes from baseline in isometric knee extension peak torque at week 16
Time Frame: Baseline and week 16
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 16
|
Changes from baseline in isometric knee extension peak torque at week 36
Time Frame: Baseline and week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 36
|
Changes from week 16 in isometric knee extension peak torque at week 36
Time Frame: Week 16 and week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16 and week 36
|
Between group differences in isometric knee extension rate of force development at week 16
Time Frame: Week 16
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16
|
Between group differences in isometric knee extension rate of force development at week 36
Time Frame: Week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
|
Changes from baseline in isometric knee extension rate of force development at week 16
Time Frame: Baseline and week 16
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 16
|
Changes from baseline in isometric knee extension rate of force development at week 36
Time Frame: Baseline and week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 36
|
Changes from week 16 in isometric knee extension rate of force development at week 36
Time Frame: Week 16 and week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16 and week 36
|
Between group differences in upper body strength at week 16
Time Frame: Week 16
|
Determined by a handgrip dynamometer.
|
Week 16
|
Between group differences in upper body strength at week 36
Time Frame: Week 36
|
Determined by a handgrip dynamometer.
|
Week 36
|
Changes from baseline in upper body strength at week 16
Time Frame: Baseline and week 16
|
Determined by a handgrip dynamometer.
|
Baseline and week 16
|
Changes from baseline in upper body strength at week 36
Time Frame: Baseline and week 36
|
Determined by a handgrip dynamometer.
|
Baseline and week 36
|
Changes from week 16 in upper body strength at week 36
Time Frame: Week 16 and week 36
|
Determined by a handgrip dynamometer.
|
Week 16 and week 36
|
Between group differences in postural balance at week 16
Time Frame: Week 16
|
Determined by the number of falls in a single-legged flamingo balance test.
|
Week 16
|
Between group differences in postural balance at week 36
Time Frame: Week 36
|
Determined by the number of falls in a single-legged flamingo balance test.
|
Week 36
|
Changes from baseline in postural balance at week 16
Time Frame: Baseline and week 16
|
Determined by the number of falls in a single-legged flamingo balance test.
|
Baseline and week 16
|
Changes from baseline in postural balance at week 36
Time Frame: Baseline and week 36
|
Determined by the number of falls in a single-legged flamingo balance test.
|
Baseline and week 36
|
Changes from week 16 in postural balance at week 36
Time Frame: Week 16 and week 36
|
Determined by the number of falls in a single-legged flamingo balance test.
|
Week 16 and week 36
|
Between group differences in aerobic performance at week 16
Time Frame: Week 16
|
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Week 16
|
Between group differences in aerobic performance at week 36
Time Frame: Week 36
|
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Week 36
|
Changes from baseline in aerobic performance at week 16
Time Frame: Baseline and week 16
|
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Baseline and week 16
|
Changes from baseline in aerobic performance at week 36
Time Frame: Baseline and week 36
|
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Baseline and week 36
|
Changes from week 16 in aerobic performance at week 36
Time Frame: Week 16 and week 36
|
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Week 16 and week 36
|
Between group differences in total cholesterol at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in total cholesterol at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Changes from baseline in total cholesterol at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in total cholesterol at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in total cholesterol at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in high-density lipoprotein cholesterol at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in high-density lipoprotein cholesterol at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Changes from baseline in high-density lipoprotein cholesterol at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in high-density lipoprotein cholesterol at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in high-density lipoprotein cholesterol at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in low-density lipoprotein cholesterol at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in low-density lipoprotein cholesterol at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Changes from baseline in low-density lipoprotein cholesterol at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in low-density lipoprotein cholesterol at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in low-density lipoprotein cholesterol at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in triglycerides at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in triglycerides at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Changes from baseline in triglycerides at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in triglycerides at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in triglycerides at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in fasting glucose at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in fasting glucose at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Changes from baseline in fasting glucose at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in fasting glucose at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in fasting glucose at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in fasting insulin at week 16
Time Frame: Week 16
|
Determined by an automated analyser.
|
Week 16
|
Between group differences in fasting insulin at week 36
Time Frame: Week 36
|
Determined by an automated analyser.
|
Week 36
|
Change from baseline in fasting insulin at week 16
Time Frame: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
Change from baseline in fasting insulin at week 36
Time Frame: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
Change from week 16 in fasting insulin at week 36
Time Frame: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
Between group differences in glucose tolerance at week 16
Time Frame: Week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16
|
Between group differences in glucose tolerance at week 36
Time Frame: Week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 36
|
Changes from baseline in glucose tolerance at week 16
Time Frame: Baseline and week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 16
|
Changes from baseline in glucose tolerance at week 36
Time Frame: Baseline and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 36
|
Changes from week 16 in glucose tolerance at week 36
Time Frame: Week 16 and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16 and week 36
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CEFADE202019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Menopause
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Riphah International UniversityCompleted
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Englewood Hospital and Medical CenterNanohealth, Inc.WithdrawnMenopause SymptomsUnited States
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Englewood Hospital and Medical CenterNanohealth, Inc.CompletedMenopause SymptomsUnited States
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S.LAB (SOLOWAYS)Center of New Medical TechnologiesCompletedMenopause SymptomsRussian Federation
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University of Colorado, DenverCompletedMenopause | Pre-menopauseUnited States
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Singapore General HospitalRecruitingMenopause | Menopause Related ConditionsSingapore
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University of ArkansasRecruitingMenopause Related ConditionsUnited States
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Wake Forest University Health SciencesWithdrawnMenopause Related Conditions
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I.M. Sechenov First Moscow State Medical UniversityCompletedMenopause Related ConditionsRussian Federation
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University of Colorado, Colorado SpringsEast Carolina UniversityRecruitingMenopause | Menopause Related Conditions | Menopause SyndromeUnited States
Clinical Trials on Recreational team handball
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University Institute of MaiaUniversity of Southern Denmark; Universidade do Porto; Research Centre in Physical... and other collaboratorsCompleted
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University College of Northern DenmarkThe Danish Diabetes Association; Research Unit of General Practice, Aalborg; Danish...Completed
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University Institute of MaiaUniversity of Southern DenmarkCompletedHypertension | Blood Pressure | Blood Pressure Disorders | Hypertension,EssentialPortugal
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University of Southern DenmarkEuropean Research CouncilCompleted
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Pınar KuyuluCompletedHealth, Subjective | Muscle Strength | Activity, MotorTurkey
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Emory UniversityNational Cancer Institute (NCI)Completed
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Poznan University of Physical EducationPoznan University of Medical Sciences; National Science Centre, PolandActive, not recruitingHealthy Athletes Aged 18-35 YearsPoland
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Karolinska InstitutetMinistry of Health and Social Affairs, SwedenCompletedAutistic Disorder | Asperger Syndrome | Atypical AutismSweden
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University of TorontoSocial Sciences and Humanities Research Council of CanadaNot yet recruitingAging | Cognitive Decline | Physical Inactivity | Social Isolation