- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609979
EFFECTS OF DEEP WATER CORE EXERCİSES ON BALANCE AND MUSCLE STRENGTH İN SEDENTARY WOMEN (DWCE)
INVESTİGATİON OF THE EFFECTS OF DEEP WATER CORE STRENGTHENİNG EXERCİSES ON BALANCE AND MUSCLE STRENGTH İN SEDENTARY INDİVİDUALS
The aim of these clinical trials is to investigate the current effects of a 12-week deep-sea exercise program on sedentary, balance, and muscle strength. The key questions the study aimed to answer were:
- Does deep-sea exercise improve the development of sedentary dynamic and static balance?
- Does deep-sea exercise increase upper and lower extremity muscle strength?
Researchers compared an exercise group to a control group to assess exercise performance.
The experimental groups performed deep-sea exercises three times a week for 12 weeks. Dynamic balance, static balance, and muscle strength measurements were assessed at baseline, week 4, week 8, and week 12.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Aquatic physical exercise is becoming increasingly important in preventing loss of strength and balance caused by sedentary lifestyles, a critical public health issue. Therefore, the effects of deep-water abdominal strengthening exercises on balance and muscle strength in sedentary women were investigated.
Methods: A total of 16 sedentary women volunteered to participate in the study. Participants were randomly assigned to experimental and control groups, with an equal number of participants in each group. The experimental group participated in a deep-water abdominal strengthening exercise program three days a week for 12 weeks, while the control group did not participate in any exercise intervention. Participants underwent static and dynamic balance tests at four time points (baseline, weeks 4, 8, and 12), as well as one-repetition maximum (1RM) strength tests for the shoulder, chest, and leg regions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Batman
-
Batman, Batman, Turkey (Türkiye), 72000
- Semi-Olympic Indoor Swimming Pool, Batman Municipality
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Participant inclusion criteria were: (i) not having suffered any orthopedic injury (fracture, dislocation, serious musculoskeletal injury, etc.) in the past six months, (ii) being able to easily perform the exercises in the pool, (iii) having basic swimming skills to ensure their safety, and (v) committing to fully participating in 12 weeks of exercise programs and measurements.
-
Exclusion Criteria:Exclusion criteria are (i) taking any medication that could negatively affect study results and (ii) having a health condition that would prevent them from entering the water (infection, aquaphobia, or skin diseases, etc.). To maintain the study's achievements, participants who missed more than 20% (i.e., 8 or more) of the total exercise sessions during the 12-week intervention period were excluded from the study.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
The experimental group is undergoing a deep-sea strengthening exercise program three days a week for 12 weeks.
The exercise program included water-based core stabilization and strengthening exercises performed in deep water conditions.
|
Participants underwent a deep-water core strengthening exercise program in a semi-Olympic indoor swimming pool three days a week for 12 weeks under the supervision of researchers.
Each exercise session lasted approximately 45 minutes and consisted of warm-up, core strengthening, and cool-down sections.
The exercise program was planned according to the principle of progressive loading, and the number of sets and repetitions was gradually increased throughout the process.
During the exercise sessions, one instructor actively guided the participants in the pool while another instructor observed and monitored from outside the pool.
Adaptation sessions were conducted before the study to ensure the participants adapted to the water.
Muscle strength and balance measurements were evaluated at baseline and at weeks 4, 8, and 12.
No exercise-related injuries or adverse events were observed during the study.
Other Names:
|
|
No Intervention: Control Group
Participants in the control group did not participate in any structured exercise intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of physical activity level (IPAQ)
Time Frame: Baseline
|
To assess the physical activity levels of the participants, the International Economic Activity Questionnaire (IPAQ) consisting of document and 7 questions was used by Craig et al.
The survey includes questions aimed at collecting information about the frequency and duration of low, moderate, and high-intensity physical activity lasting at least 10 minutes over the past 7 days.The amount of energy required for activities is calculated using metabolic equivalents (MET).
To evaluate the scale, the MET value of each item is multiplied by the duration and day score to obtain the total physical activity score (METmin/week).
A score below 600 indicates low-intensity physical activity, a score between 600 and 3000 indicates moderate-intensity, and a score above 3000 indicates vigorous physical activity
|
Baseline
|
|
Dynamic Balance Performance
Time Frame: Baseline, week 4, week 8, and week 12
|
Dynamic balance performance was assessed using the Y Balance Test.
Participants performed single-leg reach movements on a stable surface in the front, back inward, and back outward directions.
During the test, individuals were instructed to hold their hands at hip level and place their heels on the ground.
They were also instructed to lightly touch the furthest point of the outstretched leg with their toes.
It was stated that the test would be repeated in case of any deviations from the protocol, such as falling, full landing, or the other foot touching the ground.
Three trials were performed in each direction, and the average was recorded in centimeters.
After recording the measurement data, the percentage maximum reach distance (%MaxD) was normalized according to limb length using the formula: (reach distance/limb length) × 100 = %MAXD.
This normalization allows for consistent comparisons, both between right and left limbs and among participants, taking into account variations in li
|
Baseline, week 4, week 8, and week 12
|
|
Static Balance
Time Frame: Baseline, week 4, week 8, and week 12
|
Participants' static balance was determined using the Flamingo balance test.
A board measuring 50 cm long, 4 cm high, and 3 cm wide was used to administer the Flamingo balance test.
Individuals were instructed to place their preferred foot in the center of the balance platform, keep their knee at maximum flexion with their hand on the same side, and focus on a fixed point at eye level.
The test lasted 1 minute (60 seconds), and the duration was monitored with a stopwatch.
The stopwatch was started when the individual was ready to maintain balance, and each instance of the individual losing balance and placing their other foot on the ground was recorded as a loss of balance within 60 seconds.
During this time, the timer was stopped at each loss of balance, and the individual was allowed to reposition themselves.
If the individual experienced more than 15 losses of balance within 30 seconds, the test was terminated early.
The balance test was administered to participants three times, an
|
Baseline, week 4, week 8, and week 12
|
|
One Repetition Maximum (1RM) Strength
Time Frame: Baseline, week 4, week 8, and week 12
|
Participants' maximum strength values in the shoulder, chest, and leg regions were obtained using a one-repetition maximum (1RM) test procedure in 3 different exercises (shoulder press, bench press, and leg press).
To determine 1RM, participants performed 5 repetitions using an estimated weight.
Then, the load was decreased or increased by 3.5-10 kg in each phase until the correct 1RM value was found using the correct technique, and the test continued.
The test was terminated when the individual could not complete 5 repetitions, and a 3-5 minute rest period was given between all trials requiring maximum effort to reach 1RM with the final weight between 3 and 5 repetitions.
The maximum strength values of the individuals were determined using the following formula: 1RM Formula: 100 x load (kg) / (102.78 - 2.78 x number of repetitions).
The weight successfully lifted was recorded as the maximum strength value.
|
Baseline, week 4, week 8, and week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: İbrahim CAN, Professor, Faculty of Sports Sciences, Iğdır University
- Study Director: Merve C KARTAL, PhD in Sports Sciences, Batman Municipality Sports Affairs Directorate
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DWCE-2024-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Balance
-
Jia-Ling HongRecruitingOlder Adults, Balance | Postural Balance | Balance AssessmentTaiwan
-
University of ExtremaduraActive, not recruitingOlder Adults, Balance | Postural Balance | Older Adult | Balance AssessmentSpain
-
Nigde Omer Halisdemir UniversityCompletedBalance | Dynamic BalanceTurkey (Türkiye)
-
Anhui Medical UniversityCompletedPostural Balance | Dynamic BalanceChina
-
Universidad Católica San Antonio de MurciaRecruitingGeriatric Assessment | Balance Control in Elderly | Balance Changes | Balance AssessmentSpain
-
Bezmialem Vakif UniversityCompletedCaffeine | Balance; Distorted | Coordination and Balance DisturbancesTurkey
-
Yi WangCompletedStability | Jumping Performance | Balance Training | Gymnastics Injury, Motor Learning, BalanceChina
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Taipei Medical UniversityCompleted
-
University of FloridaVillency Design Group, LLCCompletedBalanceUnited States
Clinical Trials on Deep Water Core Exercise
-
Chonbuk National University HospitalKyungpook National University HospitalCompleted
-
University of ArizonaTerminatedDehydration | Physical Exertion | Salivary Osmolar Concentration | Urinary Osmolar ConcentrationUnited States
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Federal University of Rio Grande do SulNot yet recruiting
-
University of Sao PauloCompleted
-
Ankara UniversityNot yet recruitingPsychological Resilience | Stress in University Students | Relaxation and Well-being
-
University of Novi SadCompletedPosture | Trunk Muscle EnduranceSerbia
-
Ahi Evran University Education and Research HospitalCompleted
-
University of VirginiaCompleted
-
Ankara Yildirim Beyazıt UniversityUnknownRheumatic Diseases | Fibromyalgia | ExerciseTurkey