Clinical trial NCT05295511: Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men
Official title: Dose-response Effects of a Recreational Team Handball-based Exercise Programme on Cardiovascular, Metabolic, Musculoskeletal and Physical Fitness Markers in Inactive Middle-aged and Older Male
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
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: 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: São João University Hospital Centre
name: EPIUnit, Public Health Institute, University of Porto
First posted: 2022-03-25
Enrollment: 68
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims at analyzing the dose-response effects of a recreational team handball-based exercise programme on cardiovascular, metabolic, musculoskeletal and physical fitness markers of inactive middle-aged and older men, without previous experience with the sport. The researchers hypothesized a positive weekly training frequency effect on health and physical fitness outcomes.


Eligibility criteria: Inclusion Criteria:

* Male participants; inactive with 50 or more years of age (i.e., not complying with the physical activity guidelines for the last 6 months).

Exclusion Criteria:

* Any medical contraindication to perform moderate-to-vigorous physical activity; incapacity to run or grip a ball.

Primary outcomes:
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in maximal oxygen uptake
timeFrame: Baseline and week 16
Secondary outcomes:
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in systolic blood pressure
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in diastolic blood pressure
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in resting heart rate
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android total mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in gynoid fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in android fat mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body lean mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left arm lean mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right arm lean mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in left leg lean mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in right leg lean mass
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral density
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in whole-body bone mineral content
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral density
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in lumbar spine bone mineral content
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral density
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in femur bone mineral content
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in procollagen type-1 amino-terminal propeptide
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in osteocalcin
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in carboxy-terminal type-1 collagen crosslinks
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in sclerostin
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in isometric upper body strength
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in postural balance
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in upper and lower body strength, and coordination
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in aerobic performance
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total cholesterol
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in high-density lipoprotein cholesterol
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in low-density lipoprotein cholesterol
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in triglycerides
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glycosylated haemoglobin
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glucose
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in insulin
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in total antioxidant status
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione reductase
timeFrame: Baseline and week 16
measure: Within-group changes from baseline to 16 weeks, and between-group changes in week 16, in glutathione peroxidase
timeFrame: Baseline and week 16
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: Univerisity of Maia
state: Porto
Study officials:
affiliation: University of Maia
name: Susana Póvoas
role: PRINCIPAL_INVESTIGATOR
References: