NCT05493384

Brief Summary

Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 25, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 2, 2022

Last Update Submit

August 6, 2022

Conditions

Keywords

TelerehabilitationRheumatic diseasesCOVID-19

Outcome Measures

Primary Outcomes (2)

  • Fatigue severity scale

    Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7

    2 minutes

  • Hospital Anxiety and Depression Scale

    It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety. Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression

    2 minutes

Secondary Outcomes (2)

  • Pittsburg Sleep Quality Index

    3 minutes

  • Health Assessment Questionnaire

    2 minutes

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

The Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom.

Other: Telerehabilitation Group

No Intervention group

NO INTERVENTION

No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity.

Interventions

The program will include stretching, strengthening, breathing, posture, proprioceptive, relaxation exercises and segmental extremity movements. Each exercise will be performed 10 times in a session for the first 4 weeks and 15 times for the last 4 weeks. Exercises will be performed progressively on the patients.

Telerehabilitation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 to 65
  • Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia

You may not qualify if:

  • Being pregnant
  • Diagnosed with malignancy
  • Had changes of medical treatment in the last 3 months
  • Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
  • Had regular exercise habit (minimally three days in a week)
  • Had cardiac symphtoms according to New York Heart Association

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23119, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Rheumatic DiseasesCOVID-19

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 9, 2022

Study Start

July 25, 2022

Primary Completion

October 20, 2022

Study Completion

November 20, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations