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

NCT ID: NCT03802578

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2018-09-30

Brief Summary

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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

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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

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Systemic Lupus Erythematosus Arthralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HAND EXERCISE

Intervention Type BEHAVIORAL

CONTROL GROUP

Patients in the control group continued their usual medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HAND EXERCISE

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Maria Tektonidou

Ass. Professor Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARIA TEKTONIDOU, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

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General Hospital of Athens 'Laiko'

Athens, Attica, Greece

Site Status

General Hospital of Elefsina 'Thriasio'

Elefsina, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 31958285 (View on PubMed)

Other Identifiers

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680/10-06-2016

Identifier Type: -

Identifier Source: org_study_id

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