Systemic Lupus ErythematosusNCT03802578
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
A study testing HAND EXERCISE in people with Systemic Lupus Erythematosus and Arthralgia, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Arthralgia
- What is being tested?
- HAND EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesGreece
- Study dates
- 28 Sep 2016to 30 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE patients fulfilling the SLICC classification criteria
- Upper limb arthralgias
- DASH score>10
- Stable drug regimen≥3 months
Who cannot join
- Hand fracture or surgery in last 6 months
- Physiotherapy program in last month
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
General Hospital of Athens 'Laiko'
Athens, Attica, 11527
General Hospital of Elefsina 'Thriasio'
Elefsina, Attica, 19600
About this study
Official title: The Impact of Exercise on Hand Function, on Activities of Daily Living (ADLs) Performance and Quality of Life of Patients With Systemic Lupus Erythematosus (SLE)
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
Read the detailed description
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria [age>18, upper limb arthralgias, and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score>10)] were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
- Conditions
- Systemic Lupus Erythematosus, Arthralgia
- Being tested
- HAND EXERCISE
- Keywords
- Exercise, Hand function, Quality of Life
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthralgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAND EXERCISEBehavioural
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE GROUP | Experimental | Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care. Receives: Behavioral: HAND EXERCISE |
| CONTROL GROUP | No intervention | Patients in the control group continued their usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of DASH questionnaire
Hand function was measured with DASH Questionnaire
Measured: Baseline, 6, 12, 24 weeks
Secondary outcomes (5)
change of HAQ questionnaire
Hand function was measured with HAQ Questionnaire
Measured: Baseline, 6, 12, 24 weeks
change of Grip strength
Grip strength was measured with Jamar Dynamometer
Measured: Baseline, 6, 12, 24 weeks
change of Pinch strength
Pinch strength was measured with Jamar pinch gauge
Measured: Baseline, 6, 12, 24 weeks
change of Dexterity
Dexterity was measured with Purdue Pegboard test
Measured: Baseline, 6, 12, 24 weeks
change of Quality of Life
Quality of Life was measured with LupusQoL Questionnaire
Measured: Baseline, 6, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start28 Sep 2016
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Tektonidou, National and Kapodistrian University of Athens
- Investigators
- MARIA TEKTONIDOU, Ass. Prof, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802578
- Sponsor's protocol ID
- 680/10-06-2016
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keramiotou K, Anagnostou C, Kataxaki E, Galanos A, Sfikakis PP, Tektonidou MG. The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial. RMD Open. 2020 Jan;6(1):e001141. doi: 10.1136/rmdopen-2019-001141.
PubMed 31958285
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise on Hand Function, on Activities of Daily Living (ADLs) Performance and Quality of Life of Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT03802578
- Acronym / sponsor ID
- 680/10-06-2016
- Conditions
- Systemic Lupus Erythematosus, Arthralgia
- Keywords
- Exercise, Hand function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 14 Jan 2019 (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.
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
Detailed description
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria [age>18, upper limb arthralgias, and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score>10)] were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXERCISE GROUP | Experimental | Behavioral: HAND EXERCISEPatients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care. |
| CONTROL GROUP | No intervention | –Patients in the control group continued their usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SLE patients fulfilling the SLICC classification criteria
- Upper limb arthralgias
- DASH score>10
- Stable drug regimen≥3 months
Key exclusion criteria (2 listed)
- Hand fracture or surgery in last 6 months
- Physiotherapy program in last month
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 |
|---|---|---|
| HAND EXERCISE | Behavioural | EXERCISE GROUP |
Primary outcome
change of DASH questionnaire
Time frame: Baseline, 6, 12, 24 weeks
Hand function was measured with DASH Questionnaire
5 secondary outcomes
change of HAQ questionnaire
Time frame: Baseline, 6, 12, 24 weeks
change of Grip strength
Time frame: Baseline, 6, 12, 24 weeks
change of Pinch strength
Time frame: Baseline, 6, 12, 24 weeks
change of Dexterity
Time frame: Baseline, 6, 12, 24 weeks
change of Quality of Life
Time frame: Baseline, 6, 12, 24 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 26 Nov 2024.
- Derived from this study: PubMed 31958285Keramiotou K, Anagnostou C, Kataxaki E, Galanos A, Sfikakis PP, Tektonidou MG. The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial. RMD Open. 2020 Jan;6(1):e001141. doi: 10.1136/rmdopen-2019-001141.
- 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.
MARIA TEKTONIDOU, Ass. Prof principal investigator
National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAND EXERCISE in people with Systemic Lupus Erythematosus and Arthralgia, run by National and Kapodistrian University of Athens at 2 sites in Greece.
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 4 inclusion and 2 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
change of DASH questionnaire (time frame: Baseline, 6, 12, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03802578, which also lists 1 linked publication.
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 26 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.