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

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802578
• Other study ID #: 680/10-06-2016
• Status: Completed
• Phase: N/A
• Start date: September 28, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• HAND EXERCISE

Locations

Country	Name	City	State
Greece	General Hospital of Athens 'Laiko'	Athens	Attica
Greece	General Hospital of Elefsina 'Thriasio'	Elefsina	Attica

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of DASH questionnaire	Hand function was measured with DASH Questionnaire	Baseline, 6, 12, 24 weeks
Secondary	change of HAQ questionnaire	Hand function was measured with HAQ Questionnaire	Baseline, 6, 12, 24 weeks
Secondary	change of Grip strength	Grip strength was measured with Jamar Dynamometer	Baseline, 6, 12, 24 weeks
Secondary	change of Pinch strength	Pinch strength was measured with Jamar pinch gauge	Baseline, 6, 12, 24 weeks
Secondary	change of Dexterity	Dexterity was measured with Purdue Pegboard test	Baseline, 6, 12, 24 weeks
Secondary	change of Quality of Life	Quality of Life was measured with LupusQoL Questionnaire	Baseline, 6, 12, 24 weeks