Obesity (Disorder)NCT07152028
Exercise Supervision Duration and Adherence in Obese Women
A study testing Exercise program with supervised and home-based components and Fully supervised exercise program in people with Obesity (Disorder), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Exercise program with supervised and home-based components and Fully supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2022to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Body mass index (BMI) > 30 kg/m²
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of 6- Versus 12-Week Supervised Multimodal Exercise on Health Outcomes and Adherence in Obese Women: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Obesity (Disorder)
- Being tested
- Exercise program with supervised and home-based components, Fully supervised exercise program
- Keywords
- obesity, exercise, Supervised exercise, Exercise adherence, Quality of life
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program with supervised and home-based componentsOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fully supervised exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise adherence
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.
Measured: 12 weeks
Secondary outcomes (3)
Functional lower-extremity strength and endurance
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.
Measured: Baseline, 6 weeks, 12 weeks
Functional mobility and dynamic balance
Assessed using the Timed Up and Go Test. Completion time was recorded in seconds; shorter times indicate better functional mobility and dynamic balance.
Measured: Baseline, 6 weeks, 12 weeks
Functional exercise capacity
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.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start23 Sep 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMMUHAN BAS ASLAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152028
- Sponsor's protocol ID
- E-60116787-020-237124
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of 6- Versus 12-Week Supervised Multimodal Exercise on Health Outcomes and Adherence in Obese Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT07152028
- Acronym / sponsor ID
- E-60116787-020-237124
- Conditions
- Obesity (Disorder)
- Keywords
- obesity, exercise, Supervised exercise, Exercise adherence, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1= 6-week supervised plus 6-week home-based program | Other | Other: Exercise program with supervised and home-based componentsParticipants 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. |
| Group 2= Fully supervised 12-week program | Other | Other: Fully supervised exercise programParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 60 years
- Body mass index (BMI) > 30 kg/m²
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program with supervised and home-based componentsThe 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. | Other | Group 1= 6-week supervised plus 6-week home-based program |
| Fully supervised exercise programThe 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. | Other | Group 2= Fully supervised 12-week program |
Primary outcome
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.
3 secondary outcomes
Functional lower-extremity strength and endurance
Time frame: Baseline, 6 weeks, 12 weeks
Functional mobility and dynamic balance
Time frame: Baseline, 6 weeks, 12 weeks
Functional exercise capacity
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program with supervised and home-based components and Fully supervised exercise program in people with Obesity (Disorder), run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise adherence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.