Clinical trial NCT05292261: Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women
Official title: Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
Collaborators: name: Research Center in Sports Sciences, Health Sciences and Human Development
name: Universidade do Porto
name: Laboratory of Metabolism and Exercise (LaMetEx), CIAFEL, Faculty of Sport, University of Porto
name: Centre of Research, Education, Innovation and Intervention in Sport, University of Porto
name: University of Southern Denmark
name: Porto Sports Medicine Center (IPDJ, IP)
name: Gaia City Hall
name: Portuguese Handball Federation
name: European Handball Federation
name: São João University Hospital Centre
name: EPIUnit, Public Health Institute, University of Porto
First posted: 2022-03-23
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Between group differences in peak oxygen uptake at week 16
timeFrame: Week 16
measure: Between group differences in peak oxygen uptake at week 36
timeFrame: Week 36
measure: Changes from baseline in peak oxygen uptake at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in peak oxygen uptake at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in peak oxygen uptake at week 36
timeFrame: Week 16 and week 36
Secondary outcomes:
measure: Between group differences in resting heart rate at week 16
timeFrame: Week 16
measure: Between group differences in resting heart rate at week 36
timeFrame: Week 36
measure: Changes from baseline in resting heart rate at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in resting heart rate at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in resting heart rate at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in body mass at week 16
timeFrame: Week 16
measure: Between group differences in body mass at week 36
timeFrame: Week 36
measure: Changes from baseline in body mass at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in body mass at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in body mass at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in fat mass at week 16
timeFrame: Week 16
measure: Between group differences in fat mass at week 36
timeFrame: Week 36
measure: Changes from baseline in fat mass at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in fat mass at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in fat mass at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in lean mass at week 16
timeFrame: Week 16
measure: Between group differences in lean mass at week 36
timeFrame: Week 36
measure: Changes from baseline in lean mass at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in lean mass at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in lean mass at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in lumbar spine bone mineral density at week 16
timeFrame: Week 16
measure: Between group differences in lumbar spine bone mineral density at week 36
timeFrame: Week 36
measure: Changes from baseline in lumbar spine bone mineral density at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in lumbar spine bone mineral density at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in lumbar spine bone mineral density at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in dominant femur bone mineral density at week 16
timeFrame: Week 16
measure: Between group differences in dominant femur bone mineral density at week 36
timeFrame: Week 36
measure: Changes from baseline in dominant femur bone mineral density at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in dominant femur bone mineral density at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in dominant femur bone mineral density at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in dominant femoral neck bone mineral density at week 16
timeFrame: Week 16
measure: Between group differences in dominant femoral neck bone mineral density at week 36
timeFrame: Week 36
measure: Changes from baseline in dominant femoral neck bone mineral density at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in dominant femoral neck bone mineral density at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in dominant femoral neck bone mineral density at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in lumbar spine bone mineral content at week 16
timeFrame: Week 16
measure: Between group differences in lumbar spine bone mineral content at week 36
timeFrame: Week 36
measure: Changes from baseline in lumbar spine bone mineral content at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in lumbar spine bone mineral content at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in lumbar spine bone mineral content at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in dominant femur bone mineral content at week 16
timeFrame: Week 16
measure: Between group differences in dominant femur bone mineral content at week 36
timeFrame: Week 36
measure: Changes from baseline in dominant femur bone mineral content at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in dominant femur bone mineral content at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in dominant femur bone mineral content at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in dominant femoral neck bone mineral content at week 16
timeFrame: Week 16
measure: Between group differences in dominant femoral neck bone mineral content at week 36
timeFrame: Week 36
measure: Changes from baseline in dominant femoral neck bone mineral content at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in dominant femoral neck bone mineral content at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in dominant femoral neck bone mineral content at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in osteocalcin at week 16
timeFrame: Week 16
measure: Between group differences in osteocalcin at week 36
timeFrame: Week 36
measure: Changes from baseline in osteocalcin at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in osteocalcin at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in osteocalcin at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in procollagen type-1 amino-terminal propeptide at week 16
timeFrame: Week 16
measure: Between group differences in procollagen type-1 amino-terminal propeptide at week 36
timeFrame: Week 36
measure: Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
timeFrame: Week 16
measure: Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
timeFrame: Week 36
measure: Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in sclerostin at week 16
timeFrame: Week 16
measure: Between group differences in sclerostin at week 36
timeFrame: Week 36
measure: Changes from baseline in sclerostin at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in sclerostin at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in sclerostin at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in isometric knee extension peak torque at week 16
timeFrame: Week 16
measure: Between group differences in isometric knee extension peak torque at week 36
timeFrame: Week 36
measure: Changes from baseline in isometric knee extension peak torque at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in isometric knee extension peak torque at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in isometric knee extension peak torque at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in isometric knee extension rate of force development at week 16
timeFrame: Week 16
measure: Between group differences in isometric knee extension rate of force development at week 36
timeFrame: Week 36
measure: Changes from baseline in isometric knee extension rate of force development at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in isometric knee extension rate of force development at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in isometric knee extension rate of force development at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in upper body strength at week 16
timeFrame: Week 16
measure: Between group differences in upper body strength at week 36
timeFrame: Week 36
measure: Changes from baseline in upper body strength at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in upper body strength at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in upper body strength at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in postural balance at week 16
timeFrame: Week 16
measure: Between group differences in postural balance at week 36
timeFrame: Week 36
measure: Changes from baseline in postural balance at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in postural balance at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in postural balance at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in aerobic performance at week 16
timeFrame: Week 16
measure: Between group differences in aerobic performance at week 36
timeFrame: Week 36
measure: Changes from baseline in aerobic performance at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in aerobic performance at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in aerobic performance at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in total cholesterol at week 16
timeFrame: Week 16
measure: Between group differences in total cholesterol at week 36
timeFrame: Week 36
measure: Changes from baseline in total cholesterol at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in total cholesterol at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in total cholesterol at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in high-density lipoprotein cholesterol at week 16
timeFrame: Week 16
measure: Between group differences in high-density lipoprotein cholesterol at week 36
timeFrame: Week 36
measure: Changes from baseline in high-density lipoprotein cholesterol at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in high-density lipoprotein cholesterol at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in high-density lipoprotein cholesterol at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in low-density lipoprotein cholesterol at week 16
timeFrame: Week 16
measure: Between group differences in low-density lipoprotein cholesterol at week 36
timeFrame: Week 36
measure: Changes from baseline in low-density lipoprotein cholesterol at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in low-density lipoprotein cholesterol at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in low-density lipoprotein cholesterol at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in triglycerides at week 16
timeFrame: Week 16
measure: Between group differences in triglycerides at week 36
timeFrame: Week 36
measure: Changes from baseline in triglycerides at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in triglycerides at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in triglycerides at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in fasting glucose at week 16
timeFrame: Week 16
measure: Between group differences in fasting glucose at week 36
timeFrame: Week 36
measure: Changes from baseline in fasting glucose at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in fasting glucose at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in fasting glucose at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in fasting insulin at week 16
timeFrame: Week 16
measure: Between group differences in fasting insulin at week 36
timeFrame: Week 36
measure: Change from baseline in fasting insulin at week 16
timeFrame: Baseline and week 16
measure: Change from baseline in fasting insulin at week 36
timeFrame: Baseline and week 36
measure: Change from week 16 in fasting insulin at week 36
timeFrame: Week 16 and week 36
measure: Between group differences in glucose tolerance at week 16
timeFrame: Week 16
measure: Between group differences in glucose tolerance at week 36
timeFrame: Week 36
measure: Changes from baseline in glucose tolerance at week 16
timeFrame: Baseline and week 16
measure: Changes from baseline in glucose tolerance at week 36
timeFrame: Baseline and week 36
measure: Changes from week 16 in glucose tolerance at week 36
timeFrame: Week 16 and week 36
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
state: Porto
Study officials:
affiliation: University of Maia
name: Susana Póvoas
role: PRINCIPAL_INVESTIGATOR
References: