Physical Training in Patients With POTS After Covid-19

NCT05094622 | Active Not Recruiting

• 1 other identifier: POTS-ReCov
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Covid-19 has the potential to affect physical, cognitive and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients who have had Covid-19 is the postural orthostatic tachycardia syndrome (POTS). To evaluate the effects of physical training in patients with POTS after Covid-19 a single subject design will be used (the patient is their own control). Inidividual semistructured interviews will be performed to explore and describe the patients´ experiences of the rehabilitation intervention. Participants: Patients diagnosed with POTS after Covid-19 (N=30) will be included. Procedure and outcomes: The primary outcomes are physical activity and health-related quality of life. Secondary outcomes are: physical capacity, active standing test, Malmö-POTS-questionnaire, Anxiety and depression, fatigue, self-reported outcome measure of physical function and work ability. Initially measurements will be performed several times during a period of 2-4 weeks to obtain a baseline before the intervention starts. Then the included participants will undergo a specially designed physical training program that will be performed 3 times /week during a period of 12 weeks. The intervention of physical training will consist of different exercises to enhance muscle strength and endurance. The intervention will be individually adjusted with a progression in dose, intensity, and position. The exercise is based on a program used in a previous study. Measurements will then be repeated after completion of the intervention period. A qualitative approach, with semistructured interviews, will be used to explore the patients´ experiences of the intervention, after commence of the interventional trial.

Conditions

Covid19; Post-acute Covid-19 Syndrome; Postural Orthostatic Tachycardia Syndrome

Keywords

physiotherapy; rehabilitation; physical exercise; quality of life; physical activity

Outcome Measures

Primary Outcomes (2)

• Change in Health-Related Quality of Life (HRQoL)

  Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.

  Measured before and after the intervention period of 12-16 weeks to detect a change

• Change in time in upright position and steps per day

  Measured with two accelerometers attached to upper and lower limbs to measure time (hours, minutes) in upright position during 7 consecutive days

  Measured before and after the intervention period of 12-16 weeks to detect a change

Secondary Outcomes (20)

• Change in walking distance during 6 minute walk test

  Measured before and after the intervention period of 12-16 weeks to detect a change

• Change in oxygen saturation during 6 minute walk test

  Measured before and after the intervention period of 12-16 weeks to detect a change

• Change in oxygen desaturation during 6 minute walk test

  Measured before and after the intervention period of 12-16 weeks to detect a change

• Change in dyspnea during 6 minute walk test

  Measured before and after the intervention period of 12-16 weeks to detect a change

• Change in leg fatigue during 6 minute walk test

  Measured before and after the intervention period of 12-16 weeks to detect a change

Study Arms (1)

Physical exercise

EXPERIMENTAL

Physical exercise program

Other: Physical exercise program

Interventions

Physical exercise program OTHER

A specially designed exercise training program based on a previous study. The intervention of physical exercise will consist of different exercises to enhance muscle strength and endurance and will be individually adjusted and start in a different position with a progression in dose, intensity, and position. It will be performed 3 times /week during a period of 12-20 weeks.

Physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (8)

• Fu Q, Levine BD. Exercise and non-pharmacological treatment of POTS. Auton Neurosci. 2018 Dec;215:20-27. doi: 10.1016/j.autneu.2018.07.001. Epub 2018 Jul 4.

  PMID: 30001836 BACKGROUND

• Crook H, Raza S, Nowell J, Young M, Edison P. Long covid-mechanisms, risk factors, and management. BMJ. 2021 Jul 26;374:n1648. doi: 10.1136/bmj.n1648.

  PMID: 34312178 BACKGROUND

• Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.

  PMID: 33753937 BACKGROUND

• Fedorowski A. Postural orthostatic tachycardia syndrome: clinical presentation, aetiology and management. J Intern Med. 2019 Apr;285(4):352-366. doi: 10.1111/joim.12852. Epub 2018 Nov 23.

  PMID: 30372565 BACKGROUND

• Johansson M, Stahlberg M, Runold M, Nygren-Bonnier M, Nilsson J, Olshansky B, Bruchfeld J, Fedorowski A. Long-Haul Post-COVID-19 Symptoms Presenting as a Variant of Postural Orthostatic Tachycardia Syndrome: The Swedish Experience. JACC Case Rep. 2021 Apr;3(4):573-580. doi: 10.1016/j.jaccas.2021.01.009. Epub 2021 Mar 10.

  PMID: 33723532 BACKGROUND

• Stahlberg M, Reistam U, Fedorowski A, Villacorta H, Horiuchi Y, Bax J, Pitt B, Matskeplishvili S, Luscher TF, Weichert I, Thani KB, Maisel A. Post-COVID-19 Tachycardia Syndrome: A Distinct Phenotype of Post-Acute COVID-19 Syndrome. Am J Med. 2021 Dec;134(12):1451-1456. doi: 10.1016/j.amjmed.2021.07.004. Epub 2021 Aug 11.

  PMID: 34390682 BACKGROUND

• Arnold AC, Ng J, Raj SR. Postural tachycardia syndrome - Diagnosis, physiology, and prognosis. Auton Neurosci. 2018 Dec;215:3-11. doi: 10.1016/j.autneu.2018.02.005. Epub 2018 Feb 28.

  PMID: 29523389 BACKGROUND

• Benrud-Larson LM, Dewar MS, Sandroni P, Rummans TA, Haythornthwaite JA, Low PA. Quality of life in patients with postural tachycardia syndrome. Mayo Clin Proc. 2002 Jun;77(6):531-7. doi: 10.4065/77.6.531.

  PMID: 12059122 BACKGROUND

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Postural Orthostatic Tachycardia Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Malin Nygren Bonnier, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

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: Physiotherapist, Senior lecturer and Associate Professor

Model Details: single subject design

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 26, 2021
• Study Start: January 10, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)