Clinical trial NCT06781541: Physical Activity and Disability Prevention in Postmenopausal Women
Official title: Physical Activity and Disability Prevention in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Fall Risk
Sarcopenia in Elderly
Osteopenia, Osteoporosis
Cardiovascular Diseases
Dementia
Quality of Life Outcomes
Cognitive Ability, General
Keywords: Physical activity
aerobic capacity
mobility
cognitive functions
quality of life
disability
postmenopausal women
Physical fitness
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: Chengdu University of Traditional Chinese Medicine
First posted: 2025-01-17
Enrollment: 72
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical study is to examine the impact of physical activity on the physical and mental health of postmenopausal women, with a particular focus on the development of disability. The main questions this study aims to answer are:

1. Can physical activity programs (Nordic walking, Bungy Pump, strength training, functional general conditioning training) prevent loss of mobility, bone density and urinary incontinence, reduce the risk of falls, lower metabolic syndrome parameters, and improve cardiovascular endurance in postmenopausal women?
2. Do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women?

Researchers will compare the test groups (Nordic Walking, Bungy Pump, strength training, functional general conditioning training) with the control group to determine whether physical activity brings benefits in terms of physical and mental health compared to no intervention.

Participants will:

Take part in a three-month physical activity program that includes Nordic walking, Bungy Pump exercises, functional general conditioning training and strength training, depending on the group.

The control group will not participate in any additional physical exercise program and will continue with their usual daily activities.

Detailed description: This study will involve two testing phases (pre- and post-training). Prior to the first test, participants' physical activity will be measured over a period of seven days using POLAR accelerometers to evaluate the relationship between their daily physical activity and health. Each testing phase will last two days; on the first day, blood samples will be collected, and preliminary analyses of body composition and dietary records will be conducted. On the second day, physical fitness tests and psychological test swill be performed at the AWFiS Sports Exercise Laboratory in Gdańsk. Biological materials (serum) will be frozen and subsequently tested by contractors at the AWFiS Sports Genetics Laboratory. Participants will be required to maintain a dietary diary to record their dietary intake for the three days preceding the tests.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women over 60 years old (i.e. more than 12 months since their last menstrual cycle).

There were no contraindications to exercise after case reports and initial diagnosis.

Informed consent must be signed, agreeing to participate in research and physical exercise programs.

Exclusion Criteria:

* Uncontrolled high blood pressure. Rheumatoid arthritis. Type 2 diabetes. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.

Primary outcomes:
measure: Risk of Falls
timeFrame: From enrollment to the end of treatment at 3 months
measure: Bone Density
timeFrame: From enrollment to the end of treatment at 3 months
measure: Triglycerides (Metabolic syndrome Indicators)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Total cholesterol (Metabolic syndrome Indicators)
timeFrame: From enrollment to the end of treatment at 3 months
measure: High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: From enrollment to the end of treatment at 3 months
measure: non-High Density Lipoprotein Cholesterol (no-HDL-C)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Fasting blood glucose (FBG)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Gait Speed
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal muscle index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Cognitive Abilities Assessment
timeFrame: From enrollment to the end of treatment at 3 months
measure: Quality of Life
timeFrame: From enrollment to the end of treatment at 3 months
measure: VO2max
timeFrame: From enrollment to the end of treatment at 3 months
measure: Gait
timeFrame: From enrollment to the end of treatment at 3 months
measure: Static Balance
timeFrame: From enrollment to the end of treatment at 3 months
measure: Pelvic Floor Muscle Function
timeFrame: From enrollment to the end of treatment at 3 months
measure: Daily steps
timeFrame: Physical activity levels were monitored for 7 days prior to the test
Secondary outcomes:
measure: PEAK AWY
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: PEAK TWD
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Tandem Balance
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Arm strength index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Pain pressure threshold (PPT)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Electromyography
timeFrame: From enrollment to the end of treatment at 3 months
measure: Postural Stability Test (PST)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Spatial memory assessment
timeFrame: From enrollment to the end of treatment at 3 months
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Fall-related concerns
timeFrame: From enrollment to the end of treatment at 3 months
measure: Cognitive Ability
timeFrame: From enrollment to the end of treatment at 3 months
measure: 30-Second Chair Stand
timeFrame: From enrollment to the end of treatment at 3 months
measure: Circumferences
timeFrame: From enrollment to the end of treatment at 3 months
measure: Forward Lean Test
timeFrame: From enrollment to the end of treatment at 3 months
measure: Sedentary time
timeFrame: From enrollment to the end of treatment at 3 months
measure: Adiponectin (ADPN)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Hand Strength (HS)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Skeletal Muscle Mass
timeFrame: From enrollment to the end of treatment at 3 months
measure: Myostatin
timeFrame: From enrollment to the end of treatment at 3 months
measure: Irisin
timeFrame: From enrollment to the end of treatment at 3 months
measure: BDNF
timeFrame: From enrollment to the end of treatment at 3 months
measure: Arm strength index II
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Knee extensor strength index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Knee flexor strength index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Pain tolerance (PTOL)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Pain intensity score
timeFrame: From enrollment to the end of treatment at 3 months
measure: Limits of Stability Test (LOS)
timeFrame: From enrollment to the end of treatment at 3 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Arm Curl
timeFrame: From enrollment to the end of treatment at 3 months
measure: 6-Minute Walk
timeFrame: From enrollment to the end of treatment at 3 months
measure: Chair Sit-and-Reach
timeFrame: From enrollment to the end of treatment at 3 months
measure: Back Scratch
timeFrame: From enrollment to the end of treatment at 3 months
measure: 8-Foot Up-and-Go
timeFrame: From enrollment to the end of treatment at 3 months
measure: Leptin
timeFrame: From enrollment to the end of treatment at 3 months
measure: Resistin
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
measure: Body Fat Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Fat-Free Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: BMI
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Bifidobacterium
timeFrame: From enrollment to the end of treatment at 3 months
measure: The vitamin D3 level test
timeFrame: From enrollment to the end of treatment at 3 months
measure: Blood sodium content test
timeFrame: From enrollment to the end of treatment at 3 months
measure: IL-6
timeFrame: From enrollment to the end of treatment at 3 months
measure: CRP
timeFrame: From enrollment to the end of treatment at 3 months
measure: TNF-α
timeFrame: From enrollment to the end of treatment at 3 months
measure: Assessment of food types and quantities
timeFrame: From enrollment to the end of treatment at 3 months
measure: Visuomotor coordination (average deviation from the correct angle)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Spinal Pain Assessment (Neck Disability Index)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Reaction speed assessment
timeFrame: From enrollment to the end of treatment at 3 months
measure: Range of motion
timeFrame: From enrollment to the end of treatment at 3 months
measure: Skinfold thickness measurement
timeFrame: From enrollment to the end of treatment at 3 months
measure: Mood
timeFrame: From enrollment to the end of treatment at 3 months
measure: Assessment of exercise motivation
timeFrame: From enrollment to the end of treatment at 3 months
measure: Assessment of self-esteem level
timeFrame: From enrollment to the end of treatment at 3 months
measure: Lactobacillus
timeFrame: From enrollment to the end of treatment at 3 months
measure: Test of potassium content in the blood
timeFrame: From enrollment to the end of treatment at 3 months
measure: Creatinine
timeFrame: From enrollment to the end of treatment at 3 months
measure: Creatine kinase
timeFrame: From enrollment to the end of treatment at 3 months
measure: Uric acid
timeFrame: From enrollment to the end of treatment at 3 months
measure: Albumin
timeFrame: From enrollment to the end of treatment at 3 months
measure: Total protein
timeFrame: From enrollment to the end of treatment at 3 months
measure: ALT
timeFrame: From enrollment to the end of treatment at 3 months
measure: AST
timeFrame: From enrollment to the end of treatment at 3 months
measure: Test of calcium content in the blood
timeFrame: From enrollment to the end of treatment at 3 months
measure: Magnesium content test in the blood
timeFrame: From enrollment to the end of treatment at 3 months
measure: Red blood cells
timeFrame: From enrollment to the end of treatment at 3 months
measure: Leukocytes
timeFrame: From enrollment to the end of treatment at 3 months
measure: Platelets
timeFrame: From enrollment to the end of treatment at 3 months
measure: Hemoglobin level
timeFrame: From enrollment to the end of treatment at 3 months
measure: Food calorie assessment
timeFrame: From enrollment to the end of treatment at 3 months
measure: Visuomotor coordination (deviations from horizontal/vertical lines)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Visuomotor coordination (time spent in the ideal range)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Spinal Pain Assessment (Oswestry Disability Index)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Faecalibacterium
timeFrame: From enrollment to the end of treatment at 3 months
measure: Enterobacteriaceae
timeFrame: From enrollment to the end of treatment at 3 months
measure: Sleep Quality
timeFrame: From enrollment to the end of treatment at 3 months
Locations:
city: Gdansk
country: Poland
facility: Gdansk University of Physical Education and Sport
state: Województwo Pomorskie
Study officials:
affiliation: AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTU
name: Zbigniew Ossowski, PHD
role: STUDY_CHAIR
affiliation: Chengdu University of Traditional Chinese Medicine
name: Yangjun Liu, PHD
role: PRINCIPAL_INVESTIGATOR
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