Change in Disease Activity with Exercise Tolerance in Persons with Ankylosing Spondylitis on Adalimumab Therapy
Phase 4
- Conditions
- Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
- Registration Number
- CTRI/2019/01/016947
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Diagnosed cases of AS on Adalimumab therapy from any Department at AIIMS, New Delhi
2. Those who are willing to participate in the study
Exclusion Criteria
1.Any neurological disorders such as stroke, Parkinsonâ??s disease, Traumatic brain injury, Seizure disorder
2.Cognitive impairments
3.Vestibular problems like vertigo, dizziness or ringing of ear
4.Any visual impairment that canâ??t be corrected by glasses
5.Previous surgery at spine and on lower extremities
6.Pregnancy
7.Active substance or alcohol abuse
8.Other disabling medical (Diabetes Mellitus, Uncontrolled hypertension) or psychiatric
Co - Morbidities
9.Patients on Biologicals other than Adalimumab.
10. Patients who are unwilling to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess change in <br/ ><br>a)Disease activity using BASDAI <br/ ><br>b)Exercise tolerance using the 6 minute walk test in patients with AS while on Adalimumab therapy <br/ ><br>2.To correlate change in disease activity with exercise tolerance <br/ ><br>Timepoint: Baseline, 2 weeks and 4 weeks
- Secondary Outcome Measures
Name Time Method To correlate change in disease activity with exercise toleranceTimepoint: Baseline, 2 weeks and 4 weeks