NCT05435456

Brief Summary

The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), Pittsburgh sleep quality index (PSQI) before and after the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 26, 2022

Last Update Submit

June 26, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • McGill Pain Scale short form (SFMPQ)

    It gives an information about the sensation, severity and effect of pain

    at the enrollment and after the study

  • Short-Form 36 (SF-36)

    It asses general quality of life with 8 parameters

    at the enrollment and after the study

  • Pittsburg Sleep Quality Index

    It asses sleep quality with 19 questions that each question scored between 0-3.

    at the enrollment and after the study

  • Beck Anxiety Scale

    It asses anxiety levels with subjective and somatic factors

    at the enrollment and after the study

Study Arms (2)

Experimental Group

EXPERIMENTAL

Performed strengthening and relaxation exercises 3 times a week for 8 weeks.

Other: Exercise

Control Group

NO INTERVENTION

There is no intervention

Interventions

Strengthening and Relaxation Exercises

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • to be between the ages of 18-65
  • to be diagnosed with Covid-19 in the last 3 months
  • to have a negative PCR test, or to have completed the 14-day isolation period

You may not qualify if:

  • have undergone surgery in the last 6 months
  • have severe mental retardation that would prevent communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

    PMID: 32644129BACKGROUND
  • Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seda Saka, PhD

    Haliç University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seda Saka

Study Record Dates

First Submitted

June 26, 2022

First Posted

June 28, 2022

Study Start

January 18, 2021

Primary Completion

March 31, 2021

Study Completion

July 8, 2021

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations