NCT07152028

Brief Summary

Obesity is one of the most common health problems worldwide and is associated with many chronic diseases. Regular physical activity is known to play an important role in weight control, balance, quality of life, and mental health. However, obese individuals often have low adherence to exercise programs, and long-term maintenance of physical activity remains a major challenge. Previous studies have shown that supervised exercise programs are effective in improving functional capacity and psychological well-being. On the other hand, home-based programs are less costly and more accessible, but adherence and effectiveness may be limited without professional supervision. To date, there is limited evidence on the optimal supervision duration needed to achieve sustainable improvements in obese women. In the present study, it is aimed to investigate the effects of a 12-week individualized multimodal exercise program with different supervision durations (6 weeks supervised + 6 weeks home-based vs. 12 weeks fully supervised) on adherence and health outcomes in obese women. It is thought that prolonged supervision may increase exercise adherence, improve balance and functional performance, reduce depressive symptoms, and contribute positively to the quality of life. The results of this study may guide the design of future exercise programs for obesity management and provide evidence for more effective and sustainable rehabilitation approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 23, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

August 25, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

obesityexerciseSupervised exerciseExercise adherenceQuality of life

Outcome Measures

Primary Outcomes (1)

  • Exercise adherence

    Adherence to the exercise program was assessed by the percentage of completed exercise sessions recorded in exercise diaries (participant-reported), attendance checklists maintained by the supervising physiotherapist during supervised sessions, and weekly telephone follow-up logs during the home-based phase (weeks 7-12 for Group 1).

    12 weeks

Secondary Outcomes (3)

  • Functional lower extremity strength

    Baseline, 6 weeks, 12 weeks

  • Balance

    Baseline, 6 weeks, 12 weeks

  • Aerobic exercise capacity

    Baseline, 6 weeks, 12 weeks

Other Outcomes (3)

  • Health-related quality of life

    Baseline, 6 weeks, 12 weeks

  • Depressive symptoms

    Baseline, 6 weeks, 12 weeks

  • Physical activity level

    Baseline, 6 weeks, 12 weeks

Study Arms (2)

Group 1= 6-week supervised plus 6-week home-based program

OTHER

Participants perform a 12-week multimodal exercise program targeting balance, muscular strength, core endurance, and cardiovascular fitness. Weeks 1-6 are supervised; weeks 7-12 are home-based via a video catalogue. Walking ≥30 min on ≥2 non-training days is encouraged.

Other: Exercise program with supervised and home-based components

Group 2= Fully supervised 12-week program

OTHER

Participants perform a fully supervised 12-week multimodal exercise program including warm-up, balance, aerobic, strength, and core exercises. Walking ≥30 min on ≥2 non-training days is included.

Other: Fully supervised exercise program

Interventions

The 12-week program targets balance, muscular strength, core endurance, and cardiovascular fitness. Weeks 1-6 are supervised; weeks 7-12 are home-based via a video catalogue. Walking ≥30 min on ≥2 non-training days is advised. Intensity, repetitions, and sets are individualized using Borg CR-6-20. Adherence is monitored via exercise diaries and weekly phone calls with adjustments as needed.

Group 1= 6-week supervised plus 6-week home-based program

The 12-week program is fully supervised and includes warm-up, balance, aerobic, strength, and core exercises. Walking ≥30 min on ≥2 non-training days is included. Intensity, repetitions, and sets are individualized using Borg CR-6-20. Adherence is monitored by a physiotherapist using exercise diaries.

Group 2= Fully supervised 12-week program

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 60 years
  • Body mass index (BMI) \> 30 kg/m²

You may not qualify if:

  • Clinically unstable cardiopulmonary disease (e.g., recent myocardial infarction, unstable angina)
  • Musculoskeletal or neuromuscular disorders
  • Cognitive impairments that could limit exercise participation
  • Use of medications affecting bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 3, 2025

Study Start

September 23, 2022

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations