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NCT Number: NCT03802578

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Arthralgia Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Athens 'Laiko', Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAND EXERCISE

Behavioral

Primary outcomes

  1. change of DASH questionnaire

    Time frame: Baseline, 6, 12, 24 weeks

    Hand function was measured with DASH Questionnaire

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2019
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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