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

Menopause Clinical Trial

— H4HW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292261
• Other study ID #: CEFADE202019
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2022
• Source: University Institute of Maia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Other:
• Recreational team handball
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.

Locations

Country	Name	City	State
Portugal	University of Maia	Maia	Porto

Sponsors (13)

Lead Sponsor

Collaborator

University Institute of Maia

Centre of Research, Education, Innovation and Intervention in Sport, University of Porto, EPIUnit, Public Health Institute, University of Porto, European Handball Federation, Gaia City Hall, Laboratory of Metabolism and Exercise (LaMetEx), CIAFEL, Faculty of Sport, University of Porto, Porto Sports Medicine Center (IPDJ, IP), Portuguese Handball Federation, Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, São João University Hospital Centre, Universidade do Porto, University of Southern Denmark

Country where clinical trial is conducted

Portugal, 

Outcome

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