- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536893
Effect of Tai Chi and Multimodal Exercise in Overweight and Obese Women
The Effect of Tai Chi and Multimodal Exercise Programs on Balance in Overweight and Obese Women
Obesity is a health problem that results from the interaction of genetic, socio-economic, and socio-cultural factors, leading to excessive accumulation of body fat that harms the body and poses a risk to health. Excess weight and obesity negatively affect the musculoskeletal system, leading to limitations associated with physical functionality. In overweight and obese individuals, the musculoskeletal system experiences increased stress on bones, joints, and soft tissues. This causes balance and gait disorders, frequently leading to injuries from falls.
Regular exercise is known to play a significant role in regulating energy balance, reducing the risk of obesity-related health problems, and decreasing the morbidity and mortality associated with these problems. However, while the literature shows numerous weight-focused studies on excess weight and obesity, intervention and comparative studies aimed at improving balance ability as a primary goal affecting an individual's physical mobility are limited. Furthermore, studies examining the effects of tai chi and multimodal exercise training on overweight and obese individuals are also limited.
In the present study, it is aimed to examine the effects of a 10-week Tai Chi and Multimodal exercise program on balance in overweight and obese women, and to compare the effectiveness of Tai Chi and Multimodal exercises.
The results of this study can guide the development of exercise programs to be used in the treatment of obesity and provide a scientific basis for creating more effective and sustainable rehabilitation strategies in the long term.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of overweight and obesity is increasing significantly, impacting public health. Obesity, which has become a global public health problem, is a chronic and progressive condition. The main reason for the increasing prevalence of obesity today is sedentary lifestyle. A sedentary lifestyle is associated with obesity, multiple complications of obesity, and an increased risk of mortality.
Exercise when performed regularly and appropriately, exerts protective effects against obesity-related diseases by reducing cardiovascular and cardiometabolic health risks and enhancing functional capacity through increases in muscle mass and strength. Falls in obese adults are a serious public health problem associated with irreversible health consequences, it is necessary to identify the best choices among evidence-based interventions to prevent fall-causing factors (reduced balance, poor postural stability). In this regard, multimodal exercise includes aerobic, strength, balance, and flexibility activities. Furthermore, obese individuals cannot sustain intense and strenuous exercise. When they do, intense and strenuous exercise can lead to serious muscle injuries. Therefore, Tai chi is used as an aerobic exercise for obese people. In this context, it is important to investigate the effectiveness of various exercise programs and which exercise program is most effective in overweight and obese individuals.
Participants were randomly assigned to three groups using computer-assisted randomization: Tai chi group (TCG), Multimodal group (MMG), and control group (CG). The control group received no intervention and participants were asked to continue their daily routines. The intervention groups (Tai chi and Multimodal exercise groups) underwent an exercise program lasting 45-60 minutes, twice a week, for 10 weeks. The Tai chi exercise program consisted of a 10-minute warm-up, Tai chi exercises, and a 10-minute cool-down period. The Multimodal exercise program consisted of a 10-minute warm-up, Multimodal exercises, and a 10-minute cool-down period.
Each participant who volunteered to be included in the study was given detailed information about the study, and written informed consent was obtained from those who met the inclusion criteria. During the evaluation process, participants' demographic and clinical data were recorded using a prepared form. Balance level was assessed using performance tests with proven validity and reliability. The participants were informed about the study and the evaluation processes were carried out by the same physiotherapist.
The aim of this study was to examine the effects of 10-week Tai Chi and Multimodal exercise programs on balance in overweight and obese women and to compare the effectiveness of Tai Chi and Multimodal exercises.
The findings of this study may provide a scientific basis for future research and contribute to the existing literature.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Denizli
-
Denizli, Denizli, Turkey (Türkiye)
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index (BMI) ≥25 kg/m².
- Being between 18-60 years old.
- Willingness to participate.
Exclusion Criteria:
- Conditions that prevent exercise training; cognitive impairment, musculoskeletal or neuromuscular disorders.
- Pregnancy.
- Using medications that affect bone metabolism.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai chi group (TCG)
Participants followed an exercise program for 10 weeks, 2 days a week, lasting 45-60 minutes each time.
The movements were primarily slow, fluid, and continuous, performed mainly in a semi-squat position.
The Tai chi exercise program consisted of a 10-minute warm-up, Tai chi exercises, and a 10-minute cool-down period.
|
The 10-week program aimed to improve balance skills.
Exercise intensity was adjusted using the Borg Perceived Exertion Rating scale.
Tai chi exercise; involved movements performed slowly, fluidly, and continuously, primarily in a semi-squat position.
Intervention was conducted in a standing position.
Exercise programs were conducted in groups and the difficulty level was gradually increased.
|
|
Experimental: Multimodal group (MMG)
Participants followed an exercise program for 10 weeks, 2 days a week, lasting 45-60 minutes each time.
Exercise included aerobic, strength, balance, and flexibility activities.
The multimodal exercise program consisted of a 10-minute warm-up, multimodal exercises, and a 10-minute cool-down period.
|
The 10-week program aimed to improve balance skills.
Exercise intensity was adjusted using the Borg Perceived Exertion Rating scale.
Multimodal exercise included aerobic, strength, balance, and flexibility activities.
Exercise interventions were conducted in standing, sitting, and supine positions.
Exercise programs were conducted in groups and the difficulty level was gradually increased.
|
|
No Intervention: Control group (CG)
The control group received no intervention and participants were asked to continue their daily routines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Y-Balance Test
Time Frame: Baseline and end of intervention (10 weeks)
|
The test area was created by attaching a measuring tape to a flat surface.
Participants were asked to stand on one leg at the midpoint of the test setup (the setup created with the measuring tape), with their hands placed on their iliac crests, without shoes.
They were instructed to maintain balance and touch the tip of their toe to the maximum distance without lifting the heel of their foot from the ground, moving anteriorly, posteromedially, and posterolaterally with the other leg.
If the hands left the iliac crests or balance was lost during the test, the test was terminated and repeated.
To eliminate the learning effect, participants were allowed to try the test four times in each direction before evaluation.
The test was repeated three times in each direction and applied to both lower extremities.
The distance reached with the toes was recorded in centimeters using the measuring tape.
|
Baseline and end of intervention (10 weeks)
|
|
Four Square Step Test (FSST)
Time Frame: Baseline and end of intervention (10 weeks)
|
This functional task and cognitive function test assesses dynamic balance ability.
Four squares are created on a flat surface using tape.
The squares are numbered 1-2-3-4.
Before the test begins, the participant is instructed to lift their foot as quickly as possible, step without touching the tape, and ensure both feet touch the ground in each square.
The participant is given one attempt to remember the sequence.
The test is repeated if the participant fails to complete the sequence successfully, loses balance, or touches the tape.
The test time starts when the participant's first foot touches the second square and ends when the last foot touches the first square.
The test result is recorded in seconds (s).
|
Baseline and end of intervention (10 weeks)
|
|
Timed Up and Go (TUG) test time
Time Frame: Baseline, end of intervention (10 weeks)
|
The test used a chair approximately 45 cm high.
Participants were asked to stand up from the chair, walk 3 meters at a comfortable pace, pass and turn around a marker on the floor, walk back to the chair, and sit down.
A time taken to complete the test of ≥13.5 seconds indicates individuals at high risk of falling.
A shorter time indicates better functional performance.
The test was administered twice.
|
Baseline, end of intervention (10 weeks)
|
|
Single-leg stance test time
Time Frame: Baseline and end of intervention (10 weeks)
|
For the test, the person is asked to balance on one leg, and the time they maintain their balance is recorded in seconds.The test involved standing on one leg for 60 seconds; the test was terminated if there was any swaying from side to side, loss of balance, or the foot touching the ground.
The test was repeated twice for each extremity.
|
Baseline and end of intervention (10 weeks)
|
|
Five Times Sit to Stand Test
Time Frame: Baseline and end of intervention (10 weeks)
|
The 5-repetition sit-up test is used to assess fall risk, endurance, and functional strength.
Participants were instructed to cross their arms over their chest and stand up fully and then sit down fully again as quickly as possible, five times.
The test was administered twice.
The test result was recorded in seconds (s).
|
Baseline and end of intervention (10 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Baseline and end of intervention (10 weeks)
|
Body mass index calculated as body weight in kilograms divided by height in meters squared.
|
Baseline and end of intervention (10 weeks)
|
|
Exercise Diary
Time Frame: After each exercise session (for 10 weeks)
|
Participants' adherence to the exercise program was evaluated using an exercise diary.
The exercise diary recorded whether participants attended the exercise session, the reason for absence if absent, the degree of exertion felt using the Borg scale, and any complaints after the exercise session.
The date of the exercise session and the week of the exercise program were also recorded in the exercise diary.
|
After each exercise session (for 10 weeks)
|
|
Waist Circumference
Time Frame: Baseline and end of intervention (10 weeks)
|
Waist circumference was measured at the level of the superior iliac crest using a tape measure.
A waist circumference of >80 cm in women and >94 cm in men is associated with an increased risk of metabolic complications.
|
Baseline and end of intervention (10 weeks)
|
|
Rating of Perceived Exertion
Time Frame: Baseline and end of intervention (10 weeks)
|
Post-training perceived difficulty was assessed using a 15-point (6-20) Borg scale.
The Borg scale identifies somatic symptoms and requires participants to express the degree to which their bodies were strained after exercise.
The effort level on the scale is rated as follows; 6 (no exertion/rest), 7 (very, very light), 9 (very light), 11 (light), 13 (somewhat hard), 15 (hard), 17 (very hard), 19 (extremely hard), and 20 (maximal exertion).
The effort level felt by participants after each session was recorded using the Borg scale.
|
Baseline and end of intervention (10 weeks)
|
|
Leg Length
Time Frame: Baseline and end of intervention (10 weeks)
|
Leg length was measured and recorded from the anterior superior iliac joint to the distal part of the medial malleolus.
Leg length was measured to normalize the Y-Balance Test results.
|
Baseline and end of intervention (10 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ummuhan Baş Aslan, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
- Principal Investigator: Eda Aydın, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
- Principal Investigator: Raziye Şavkın, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-643319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Overweight and Obesity
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
National Taiwan University HospitalCompleted
-
PfizerNot yet recruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasRecruitingPediatric Obesity | Pediatric Overweight | Overweight , ObesityUnited States
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
Clinical Trials on Tai chi exercise
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...Not yet recruiting
-
Universidade Estadual Paulista Júlio de Mesquita...Fundação de Amparo à Pesquisa do Estado de São PauloNot yet recruiting
-
Anhui Medical UniversityCompletedRandomized Clinical Trial | Intestinal Flora | Exercise Intervention | Tai Chi ChuanChina
-
China Medical University HospitalRecruiting
-
Chungnam National UniversityNational Research Foundation of KoreaRecruiting
-
Texas Tech University Health Sciences CenterCompletedKnee Osteoarthritis | Mind-body ExerciseUnited States
-
Chinese University of Hong KongCompletedOsteoarthritis, Knee | Exercise Training | Tai ChiHong Kong
-
The University of Hong KongCompleted
-
University of Massachusetts, BostonNational Institute on Aging (NIA)Completed