NCT07536893

Brief Summary

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. This study shows that a 10-week Tai Chi and Multimodal exercise program significantly improves balance parameters and can be used to enhance balance ability without posing any risks. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 11, 2026

Last Update Submit

April 11, 2026

Conditions

Keywords

Multimodal exerciseTai chi exerciseBalanceWomenOverweight and obesityExercise programsBalance exercises

Outcome Measures

Primary Outcomes (5)

  • Timed Up and Go (TUG) test time

    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 and the best performance was accepted as the final result.

    Baseline, end of intervention (10 weeks)

  • Single-leg stance test time

    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. The highest score was considered the best result.

    Baseline and end of intervention (10 weeks)

  • Y-Balance Test

    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)

  • Five Times Sit to Stand Test

    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). The participant's best performance (shortest time) was considered the test result.

    Baseline and end of intervention (10 weeks)

  • Four Square Step Test (FSST)

    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)

Secondary Outcomes (5)

  • Body Mass Index

    Baseline and end of intervention (10 weeks)

  • Waist Circumference

    Baseline and end of intervention (10 weeks)

  • Leg Length

    Baseline and end of intervention (10 weeks)

  • Rate of Perceived Exertion (Borg RPE 15)

    Baseline and end of intervention (10 weeks)

  • Exercise Diary

    After each exercise session (for 10 weeks)

Study Arms (3)

Tai chi group (TCG)

EXPERIMENTAL

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.

Other: Tai chi exercise

Multimodal group (MMG)

EXPERIMENTAL

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.

Other: Multimodal Exercise

Control group (CG)

NO INTERVENTION

The control group received no intervention and participants were asked to continue their daily routines.

Interventions

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.

Multimodal group (MMG)

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.

Tai chi group (TCG)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) ≥25 kg/m².
  • Being between 18-60 years old.
  • Willingness to participate.

You may not qualify if:

  • Conditions that prevent exercise training; cognitive impairment, musculoskeletal or neuromuscular disorders.
  • Pregnancy.
  • Using medications that affect bone metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University, Faculty of Physiotherapy and Rehabilitation

Denizli, Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Ummuhan Baş Aslan

    Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye

    STUDY DIRECTOR
  • Eda Aydın

    Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye

    PRINCIPAL INVESTIGATOR
  • Raziye Şavkın

    Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to three groups-Tai Chi Group (TCG), Multimodal Group (MMG), and Control Group (CG)-using a computer-assisted randomization method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Faculty of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

February 21, 2025

Primary Completion

April 11, 2025

Study Completion

June 23, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations