NCT01755832

Brief Summary

The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 9, 2015

Status Verified

December 1, 2012

Enrollment Period

2.1 years

First QC Date

December 15, 2012

Last Update Submit

January 8, 2015

Conditions

Keywords

inflammatory rheumatic joint diseasetext message> 18 yearsNorwegian speaking

Outcome Measures

Primary Outcomes (4)

  • Activity

    How much do your health problems affect your ability to conduct daily activities? The outcome is assessed on a ten-point rating scale ranging from zero to ten with "0" representing "no affect" and "10" representing "extreme affect".

    40 weeks

  • Pain

    How much pain do you have at present? The outcome is measured on a ten-point numeric rating scale (NRS) ranging from zero to ten with "0" representing "no pain" and "10" representing "extreme pain".

    40 weeks

  • Fatigue

    How much fatigue do you have at present? The outcome is assesses on a ten-point rating scale ranging from zero to ten with "0" representing "no fatigue" and "10" representing "extreme fatigue"

    40 weeks

  • Stiffness

    How much stiffness do you have at present? The outcome is assessed on a ten-point numeric rating scale with "0" representing "no stiffness" and "10" representing "extreme stiffness".

    40 weeks

Study Arms (1)

Pool exercise group

Patients with inflammatory rheumatic disease

Procedure: Pool exercise

Interventions

Pool exercisePROCEDURE

Group exercise in heated pool one hour per week for 12 weeks.

Pool exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inflammatory rheumatic joint diseases with a medical referral to group exercises in heated pool.

You may qualify if:

  • Referral from a medical doctor to group exercises in heated pool
  • Inflammatory rheumatic joint disease
  • \> 18 years
  • Stable disease
  • Mobile phone owner
  • Understand and use text messages on mobile phones

You may not qualify if:

  • Independent living
  • Joint surgery previous to the study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National resource center for rehabilitation in rheumatology

Oslo, 0319, Norway

Location

Related Links

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anne Christie, Ph.D.

    National resource centre for rehabilitation in rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

December 15, 2012

First Posted

December 24, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

January 9, 2015

Record last verified: 2012-12

Locations