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Completed

NCT Number: NCT07152028

Exercise Supervision Duration and Adherence in Obese Women

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.

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Key information

Conditions

Obesity (Disorder) Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

About this study

Obesity is one of the leading public health problems worldwide and is strongly associated with cardiovascular diseases, diabetes, musculoskeletal disorders, and psychological problems. In addition to medical complications, obesity also negatively affects quality of life, daily activities, and mental well-being. According to epidemiological studies, the prevalence of obesity is steadily increasing, particularly among women, and this situation creates a serious burden on health systems.

Regular physical activity is one of the most effective non-pharmacological methods for the management of obesity. Exercise improves cardiovascular health, increases muscle strength, supports balance, reduces depressive symptoms, and contributes to weight control. Despite these benefits, adherence to exercise programs in obese individuals is often low, and sustaining physical activity over the long term remains a challenge.

Previous studies have reported that supervised exercise programs are more effective in ensuring adherence and providing functional and psychological benefits compared to unsupervised programs. However, home-based exercise programs are easier to access, more cost-effective, and provide flexibility in daily life. Nevertheless, lack of professional supervision may reduce motivation and exercise quality, leading to lower adherence and limited health benefits.

Physiotherapy and rehabilitation interventions for obesity generally include aerobic training, muscular endurance and strengthening exercises, posture and balance training, and core stabilization. Multimodal exercise programs that combine these approaches can improve both physical and psychological outcomes. Still, the optimal supervision duration in such exercise programs has not been clearly defined in the literature. While some studies emphasize the advantages of fully supervised training, others suggest that partial supervision combined with home-based practice may also be effective.

In this context, it is important to investigate whether extended supervision provides superior outcomes compared to a shorter period of supervision followed by home-based training. This information may help clinicians to design exercise programs that are both effective and sustainable for obese patients.

The present study aims to examine 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) in obese women. The investigators hypothesize that longer supervision will improve adherence, enhance functional capacity and balance, reduce depressive symptoms, and increase overall quality of life. The results of this study are expected to contribute to the development of more effective and practical rehabilitation approaches for the management of obesity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Exercise program with supervised and home-based components

Other

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 6-20 RPE scale. Adherence is monitored via exercise diaries and weekly phone calls with adjustments as needed.

Fully supervised exercise program

Other

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 6-20 RPE scale. Adherence is monitored by a physiotherapist using exercise diaries.

Primary outcomes

  1. Exercise adherence

    Time frame: 12 weeks

    Exercise adherence was calculated as the percentage of prescribed multimodal exercise sessions completed. Adherence was evaluated separately during weeks 1-6, when both groups received supervised exercise, and during weeks 7-12, when Group 1 transitioned to home-based exercise while Group 2 continued supervised exercise. Supervised-session attendance was documented by the physiotherapist. During the home-based phase, Group 1 documented completed sessions in exercise diaries, which were reviewed during weekly telephone follow-ups.

Secondary outcomes

  1. Functional lower-extremity strength and endurance

    Time frame: Baseline, 6 weeks, 12 weeks

    Assessed using the 30-Second Chair Stand Test. The number of correctly completed sit-to-stand repetitions was recorded; higher values indicate better functional lower-extremity strength and endurance.

  2. Functional mobility and dynamic balance

    Time frame: Baseline, 6 weeks, 12 weeks

    Assessed using the Timed Up and Go Test. Completion time was recorded in seconds; shorter times indicate better functional mobility and dynamic balance.

  3. Functional exercise capacity

    Time frame: Baseline, 6 weeks, 12 weeks

    Assessed using the 6-Minute Walk Test. The total distance walked in six minutes was recorded in meters; longer distances indicate better functional exercise capacity.

Other outcomes

  1. Health-related quality of life

    Time frame: Baseline, 6 weeks, 12 weeks

    Assessed using the Nottingham Health Profile (NHP); higher scores indicate poorer quality of life.

  2. Depressive symptoms

    Time frame: Baseline, 6 weeks, 12 weeks

    Measured using the Beck Depression Inventory (BDI); higher scores indicate more severe depressive symptoms.

  3. Physical activity level

    Time frame: Baseline, 6 weeks, 12 weeks

    Quantified using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in MET-min/week; higher scores indicate higher activity levels.

  4. Body weight

    Time frame: Baseline, 6 weeks, and 12 weeks

    Body weight was measured in kilograms using a calibrated scale, with participants wearing light clothing and no shoes. Lower values indicate lower body weight.

  5. Body mass index

    Time frame: Baseline, 6 weeks, and 12 weeks

    Body mass index was calculated as body weight in kilograms divided by height in meters squared (kg/m²). Lower values indicate lower body mass index.

  6. Intervention safety and tolerability

    Time frame: Throughout the 12-week intervention

    Safety and tolerability were evaluated by recording intervention-related adverse events, symptom exacerbations, exercise modifications or interruptions due to symptoms, and withdrawals attributed to the intervention. Post-exercise symptoms, including pain and edema, were reviewed during supervised sessions and, for Group 1 during the home-based phase, through exercise diaries and weekly telephone follow-ups. The number and proportion of participants experiencing intervention-related adverse events were summarized.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effects Of 6- Versus 12-Week Supervised Multimodal Exercise on Health Outcomes and Adherence in Obese Women: A Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 3, 2025
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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