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The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802578
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Tektonidou, National and Kapodistrian University of Athens

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Arthralgia Behavioral: HAND EXERCISE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EXERCISE GROUP
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.
Behavioral: HAND EXERCISE
No Intervention: CONTROL GROUP
Patients in the control group continued their usual medical care.



Primary Outcome Measures :
  1. change of DASH questionnaire [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Hand function was measured with DASH Questionnaire


Secondary Outcome Measures :
  1. change of HAQ questionnaire [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Hand function was measured with HAQ Questionnaire

  2. change of Grip strength [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Grip strength was measured with Jamar Dynamometer

  3. change of Pinch strength [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Pinch strength was measured with Jamar pinch gauge

  4. change of Dexterity [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Dexterity was measured with Purdue Pegboard test

  5. change of Quality of Life [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Quality of Life was measured with LupusQoL Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SLE patients fulfilling the SLICC classification criteria
  • Upper limb arthralgias
  • DASH score>10
  • Stable drug regimen≥3 months

Exclusion Criteria:

  • Hand fracture or surgery in last 6 months
  • Physiotherapy program in last month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802578


Locations
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Greece
General Hospital of Athens 'Laiko'
Athens, Attica, Greece, 11527
General Hospital of Elefsina 'Thriasio'
Elefsina, Attica, Greece, 19600
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: MARIA TEKTONIDOU, Ass. Prof National and Kapodistrian University of Athens
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Tektonidou, Ass. Professor Medical School, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03802578    
Other Study ID Numbers: 680/10-06-2016
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Tektonidou, National and Kapodistrian University of Athens:
Exercise
Hand function
Quality of Life
Additional relevant MeSH terms:
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Arthralgia
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms