NCT07891507

Brief Summary

This study evaluated whether a nurse-led tailored exercise program improves spinal mobility, functional ability, pain, and health literacy in adults aged 60 years or older with ankylosing spondylitis. Participants received five individual sessions over 2 weeks covering disease education, neck, shoulder, back, trunk, pelvic, lower-limb, and breathing exercises, and posture during daily activities, followed by home practice with telephone follow-up. Outcomes were assessed before the program and approximately 3 months after it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 17, 2026

Last Update Submit

October 17, 2026

Conditions

Ankylosing Spondylitis

Keywords

Exercise Therapy; Older Adults; Nurse-Led Intervention; Health Literacy; Spinal Mobility; Physical Function

Outcome Measures

Primary Outcomes (2)

  • Change in Spinal Mobility (Bath Ankylosing Spondylitis Metrology Index, BASMI)

    Clinician-measured composite of five mobility measurements; score 0-10, higher scores indicate greater impairment.

    Baseline and approximately 14 weeks after baseline (3 months after program completion)

  • Change in Functional Ability (Bath Ankylosing Spondylitis Functional Index, BASFI)

    Self-reported 10-item index; score 0-10, higher scores indicate worse function.

    Baseline and approximately 14 weeks after baseline (3 months after program completion)

Secondary Outcomes (2)

  • Change in Pain Intensity (Visual Analogue Scale)

    Baseline and approximately 14 weeks after baseline (3 months after program completion)

  • Change in Health Literacy (Functional, Communicative, and Critical Health Literacy Questionnaire)

    Baseline and approximately 14 weeks after baseline (3 months after program completion)

Study Arms (1)

Nurse-Led Tailored Exercise Program

EXPERIMENTAL

Older adults with ankylosing spondylitis received five individual nurse-led sessions over 2 weeks, followed by home exercise practice with telephone follow-up.

Behavioral: Nurse-Led Tailored Exercise Program

Interventions

Nurse-Led Tailored Exercise ProgramBEHAVIORAL

Five individual sessions over 2 weeks: (1) disease education and goal setting; (2) neck, arm, and shoulder exercises; (3) back, trunk, pelvic, lower-limb, and breathing exercises; (4) posture and body mechanics during daily activities; (5) consolidation and self-management. Home practice 5 days/week for 20-30 minutes using an illustrated booklet and exercise log, with twice-weekly telephone follow-up during the program.

Nurse-Led Tailored Exercise Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 years or older
  • Diagnosis of ankylosing spondylitis for at least 2 years, established by the treating rheumatologist and documented in the medical record
  • Currently receiving treatment
  • Alert and able to communicate
  • Willing to participate

You may not qualify if:

  • Other rheumatologic diseases
  • Dementia or other cognitive impairment affecting communication or consent
  • Uncorrected visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital, Rheumatology and Rehabilitation Outpatient Clinics

Sohag, Sohag Governorate, 82524, Egypt

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Mansoura University

Study Record Dates

First Submitted

October 17, 2026

First Posted

October 23, 2026

Study Start

November 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the publication (demographic and clinical characteristics, BASFI, BASMI, pain VAS, and FCC-HL scores at baseline and follow-up) will be shared with qualified researchers upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months after publication of the main results and ending 5 years after publication.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal approved by the principal investigator, for the purpose of the approved proposal only, after signing a data sharing agreement. Requests should be directed to the principal investigator by email.

Locations

EG(1)