Psoriatic ArthritisNCT05393141
The Effects of Weight Loss on Psoriatic Arthritis
A study testing diet and biopsychosocial exercise intervention in people with Psoriatic Arthritis and Obesity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Psoriatic Arthritis, Obesity
- What is being tested?
- diet and biopsychosocial exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2022to 15 Oct 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight/obese
- diagnosed with PSA
Who cannot join
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.
Read the detailed description
Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms.
- Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups.
- Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian.
- BETY exercise training will be given by a registered physiotherapist.
- The subjects will be followed for 12 weeks.
- Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at study completion.
- Conditions
- Psoriatic Arthritis, Obesity
- Being tested
- diet and biopsychosocial exercise intervention
- Keywords
- psoriatic arthritis, diet, biopsychosocial exercise
- Medical subject headings
- Arthritis, Psoriatic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and biopsychosocial exercise interventionBehavioural
dietary intervention: biopsychosocial exercise intervention:
| Study group | Role | What they receive |
|---|---|---|
| diet group | Experimental | weight loss diet intervention for 12 weeks Receives: Behavioral: diet and biopsychosocial exercise intervention |
| diet+bety group | Experimental | weight loss diet intervention for 12 weeks and exercise-based biopsychosocial approach (Cognitive Exercise Therapy Approach-BETY) intervention for 12 weeks Receives: Behavioral: diet and biopsychosocial exercise intervention |
| control group | No intervention | no intervention, control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
BMI (kilogram/metre2(kg/m2))
Measured: At the end of 3 months
DAPSA score
The score ranges from 0 to 50 points, with increased score reflect more discomfort
Measured: At the end of 3 months
Secondary outcomes (1)
Quality of Life Score
The score ranges from 0 to 100 points, with increased score reflecting improved quality of life
Measured: At the end of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 Jan 2022
- Primary completion15 Aug 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyra Oteles, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393141
- Sponsor's protocol ID
- HU-SO-2022
- Status last verified
- Dec 2022
- First submitted
- 23 May 2022
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms
- ClinicalTrials.gov ID
- NCT05393141
- Acronym / sponsor ID
- HU-SO-2022
- Conditions
- Psoriatic Arthritis, Obesity
- Keywords
- psoriatic arthritis, diet, biopsychosocial exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 May 2022 (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.
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.
Detailed description
Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms.
- Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups.
- Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian.
- BETY exercise training will be given by a registered physiotherapist.
- The subjects will be followed for 12 weeks.
- Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diet group | Experimental | Behavioral: diet and biopsychosocial exercise interventionweight loss diet intervention for 12 weeks |
| diet+bety group | Experimental | Behavioral: diet and biopsychosocial exercise interventionweight loss diet intervention for 12 weeks and exercise-based biopsychosocial approach (Cognitive Exercise Therapy Approach-BETY) intervention for 12 weeks |
| control group | No intervention | –no intervention, control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- overweight/obese
- diagnosed with PSA
Key exclusion criteria (1 listed)
- pregnancy or lactation
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 |
|---|---|---|
| diet and biopsychosocial exercise interventiondietary intervention: biopsychosocial exercise intervention: | Behavioural | diet group, diet+bety group |
Primary outcome
Weight Loss
Time frame: At the end of 3 months
BMI (kilogram/metre2(kg/m2))
DAPSA score
Time frame: At the end of 3 months
The score ranges from 0 to 50 points, with increased score reflect more discomfort
1 secondary outcome
Quality of Life Score
Time frame: At the end of 3 months
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 6 Dec 2022.
- 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 diet and biopsychosocial exercise intervention in people with Psoriatic Arthritis and Obesity, run by Hacettepe 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 1 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 6 Dec 2022. 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?
Weight Loss (time frame: At the end of 3 months). The study lists 2 primary outcomes in all. 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 6 Dec 2022.