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

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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

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE September 28, 2016
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
change of DASH questionnaire [ Time Frame: Baseline, 6, 12, 24 weeks ]
Hand function was measured with DASH Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • change of HAQ questionnaire [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Hand function was measured with HAQ Questionnaire
  • change of Grip strength [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Grip strength was measured with Jamar Dynamometer
  • change of Pinch strength [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Pinch strength was measured with Jamar pinch gauge
  • change of Dexterity [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Dexterity was measured with Purdue Pegboard test
  • change of Quality of Life [ Time Frame: Baseline, 6, 12, 24 weeks ]
    Quality of Life was measured with LupusQoL Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
Official Title  ICMJE 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)
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Arthralgia
Intervention  ICMJE Behavioral: HAND EXERCISE
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: HAND EXERCISE
  • No Intervention: CONTROL GROUP
    Patients in the control group continued their usual medical care.
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). pii: e001141. doi: 10.1136/rmdopen-2019-001141.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802578
Other Study ID Numbers  ICMJE 680/10-06-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maria Tektonidou, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MARIA TEKTONIDOU, Ass. Prof National and Kapodistrian University of Athens
PRS Account National and Kapodistrian University of Athens
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP