Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women

Study Overview
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Brief Summary
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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).

Official Title
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Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women

Conditions
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Menopause

Intervention / Treatment
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* Other: Recreational team handball


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team handball group<br>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. | Other: Recreational team handball<br>* 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.<br>|
| No Intervention: Control group<br>The control group participants were instructed to keep their regular daily physical activity for 36 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group differences in peak oxygen uptake at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Determined by whole-body dual- energy X-ray absorptiometry following standard procedures. | Week 16 | 
| Between group differences in body mass at 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 | 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 | 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 | 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 | Determined by whole-body dual- energy X-ray absorptiometry following standard procedures. | Week 16 | 
| Between group differences in fat mass at 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 | 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 | 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 | 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 | Determined by whole-body dual- energy X-ray absorptiometry following standard procedures. | Week 16 | 
| Between group differences in lean mass at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Determined by chemiluminescence method using a fully automated immunoassay system. | Week 16 | 
| Between group differences in osteocalcin at week 36 | Determined by chemiluminescence method using a fully automated immunoassay system. | Week 36 | 
| Changes from baseline in osteocalcin at week 16 | Determined by chemiluminescence method using a fully automated immunoassay system. | Baseline and week 16 | 
| Changes from baseline in osteocalcin at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Determined by chemiluminescence method using a fully automated immunoassay system. | Week 16 and week 36 | 
| Between group differences in sclerostin at week 16 | Determined by chemiluminescence method using a fully automated immunoassay system. | Week 16 | 
| Between group differences in sclerostin at week 36 | Determined by chemiluminescence method using a fully automated immunoassay system. | Week 36 | 
| Changes from baseline in sclerostin at week 16 | Determined by chemiluminescence method using a fully automated immunoassay system. | Baseline and week 16 | 
| Changes from baseline in sclerostin at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Determined by a handgrip dynamometer. | Week 16 | 
| Between group differences in upper body strength at week 36 | Determined by a handgrip dynamometer. | Week 36 | 
| Changes from baseline in upper body strength at week 16 | Determined by a handgrip dynamometer. | Baseline and week 16 | 
| Changes from baseline in upper body strength at week 36 | Determined by a handgrip dynamometer. | Baseline and week 36 | 
| Changes from week 16 in upper body strength at week 36 | Determined by a handgrip dynamometer. | Week 16 and week 36 | 
| Between group differences in postural balance at 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 | Determined by the number of falls in a single-legged flamingo balance test. | Week 36 | 
| Changes from baseline in postural balance at 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 | 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 | 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 | Determined by meters covered in the Yo-Yo intermittent endurance level 1 test. | Week 16 | 
| Between group differences in aerobic performance at 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 | 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 | 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 | 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 | Determined by an automated analyser. | Week 16 | 
| Between group differences in total cholesterol at week 36 | Determined by an automated analyser. | Week 36 | 
| Changes from baseline in total cholesterol at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Changes from baseline in total cholesterol at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Changes from week 16 in total cholesterol at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in high-density lipoprotein cholesterol at week 16 | Determined by an automated analyser. | Week 16 | 
| Between group differences in high-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Week 36 | 
| Changes from baseline in high-density lipoprotein cholesterol at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Changes from baseline in high-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Changes from week 16 in high-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in low-density lipoprotein cholesterol at week 16 | Determined by an automated analyser. | Week 16 | 
| Between group differences in low-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Week 36 | 
| Changes from baseline in low-density lipoprotein cholesterol at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Changes from baseline in low-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Changes from week 16 in low-density lipoprotein cholesterol at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in triglycerides at week 16 | Determined by an automated analyser. | Week 16 | 
| Between group differences in triglycerides at week 36 | Determined by an automated analyser. | Week 36 | 
| Changes from baseline in triglycerides at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Changes from baseline in triglycerides at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Changes from week 16 in triglycerides at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in fasting glucose at week 16 | Determined by an automated analyser. | Week 16 | 
| Between group differences in fasting glucose at week 36 | Determined by an automated analyser. | Week 36 | 
| Changes from baseline in fasting glucose at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Changes from baseline in fasting glucose at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Changes from week 16 in fasting glucose at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in fasting insulin at week 16 | Determined by an automated analyser. | Week 16 | 
| Between group differences in fasting insulin at week 36 | Determined by an automated analyser. | Week 36 | 
| Change from baseline in fasting insulin at week 16 | Determined by an automated analyser. | Baseline and week 16 | 
| Change from baseline in fasting insulin at week 36 | Determined by an automated analyser. | Baseline and week 36 | 
| Change from week 16 in fasting insulin at week 36 | Determined by an automated analyser. | Week 16 and week 36 | 
| Between group differences in glucose tolerance at 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 | Determined by an oral glucose tolerance teste, analysed by an automated analyser. | Week 36 | 
| Changes from baseline in glucose tolerance at 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 | 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 | Determined by an oral glucose tolerance teste, analysed by an automated analyser. | Week 16 and week 36 |