Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

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University College Dublin

Status and phase

Unknown
Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Other: Control group
Other: Gym exercise group intervention
Other: Hydrotherapy group exercise intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00855322
RAEx-0809

Details and patient eligibility

About

The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication

Full description

Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication. It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.

Enrollment

51 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with RA receiving anti-TNFalpha therapy medication for more than three months
  • Consenting male and female patients aged 18 - 70 years
  • Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
  • ACR functional class I, II, III

Exclusion criteria

  • Patients who have attended physiotherapy in the past three months
  • Patients to whom exercise therapy or hydrotherapy are contraindicated
  • Patients who have undergone joint surgery in the past six months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 3 patient groups

1
Experimental group
Description:
Gym group exercise intervention
Treatment:
Other: Gym exercise group intervention
2
Experimental group
Description:
Hydrotherapy group exercise intervention
Treatment:
Other: Hydrotherapy group exercise intervention
3
No Intervention group
Description:
Control group
Treatment:
Other: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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