Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03911830
• Date of registration: 01/10/2018
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness PREXCRIM
• Scientific title: Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis
• Date of first enrolment: November 11, 2017
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03911830
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient (male or female) between the ages of 20 and 80, diagnosed with rheumatoid
arthritis without any other risk factor in relation to RA, and having a DAS-28 score
between 2.6 and 6.

- Signature of informed consent

- Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

- Unstabilized corticosteroids and / or> 10 mg prednisone / day;

- Unstabilized hypertension;

- Pregnant women;

- Alteration of higher functions making comprehension and adherence to a conditioning
program impossible (mini mental test <24); Patient who has performed intense physical
exercise / physiotherapy within the previous 24 hours the interventions planned in
this project;

- Contraindication to immersion in cold water (a dermatological factor and / or vascular
or respiratory cardiac dysfunction and / or cold intolerance syndrome and / or
syndrome such as Raynaud's Syndrome);

- Inability to perform physical exercise, regardless of its origin (neurological,
central or peripheral, cardiovascular or respiratory or musculoskeletal);

- Legal incapacity or limited legal capacity;

- Subject unlikely to cooperate with the study and / or weak cooperation anticipated by
the investigator;

- Subject without health insurance;

- Subject being in the exclusion period of another study or provided for by the
"National Volunteer File".



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cryotherapy Effect

Rheumatoid Arthritis

Physical Activity

Intervention(s)

Other: Exercise followed cold water immersion

Primary Outcome(s)

Pressure wave analysis [Time Frame: Week 6]

Assessment of central arterial compliance [Time Frame: Week 6]

Secondary Outcome(s)

Cardiovascular function : blood pressure [Time Frame: Week 6]

Disease activity : articular ultrasound [Time Frame: Week 6]

Cardiovascular function : cardiac index [Time Frame: Week 6]

Disease activity : blood markers of inflammation [Time Frame: Week 6]

Disease activity : DAS-28 [Time Frame: Week 6]

Assessment of functional disability : HAQ [Time Frame: Week 6]

Assessment of quality of life and well-being (SF-36) [Time Frame: Week 6]

Assessment of physical activity (SQUASH) [Time Frame: Week 6]

Cardiovascular function : elasticity of arteries [Time Frame: Week 6]

Secondary ID(s)

P/2016/305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors