Rehabilitation in Aortic Stenosis Patients

NCT01504737 | Terminated

• 1 other identifier: RASP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of valve diseases is presented without considering the differences in pathophysiology and the training regimes are not clearly described. PURPOSE, AIMS \& HYPOTHESIS The investigators purpose is to evaluate whether a supervised cardiac rehabilitation program improves the objective physical capacity and quality of life (QoL) of patients after AVR due to AS, and compare this to patients training by their own. The investigators hypothesize that supervised exercise training may be a more efficient way of rehabilitating these patients. DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised exercise training 3 times per week to home-based training based upon public health recommendations of minimum level of physical activity. SIGNIFICANCE \& IMPLEMENTATION Positive results would support that an organized program of exercise training improves physical capacity and QoL in AS patients following AVR with potential benefit for both patients and society.

Conditions

Aortic Valve Stenosis

Keywords

Exercise; Physical Activity; Physiotherapy; Exercise test; Quality of Life; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen uptake

  Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.

  Before (within one week before intervention), 1 week after and 12 months after intervention

Secondary Outcomes (4)

• Change in Health-related Quality of Life

  Before (within one week before intervention), 1 week after and 12 months after intervention

• Change in Physical activity level

  Before (within one week before intervention), 1 week after and 12 months after intervention

• Change in hs-CRP

  Before (within one week before intervention), 1 week after and 12 months after intervention

• Change in NT-pro-BNP

  Before (within one week before intervention), 1 week after and 12 months after intervention

Study Arms (2)

Supervised Exercise Training

EXPERIMENTAL

12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.

Other: Aerobic Exercise Training

Physical Activity Recommendations

ACTIVE COMPARATOR

Written and verbal information on minimal level of physical activity recommended.

Other: Physical Activity Recommendations

Interventions

Aerobic Exercise Training OTHER

12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.

Also known as: Physiotherapy, Physical activity

Supervised Exercise Training

Physical Activity Recommendations OTHER

Written and verbal information on minimal level of physical activity recommended.

Also known as: Exercise

Physical Activity Recommendations

Eligibility Criteria

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

You may qualify if:

• Elective surgery with aortic valve replacement for aortic stenosis at the thoracic surgery department at Linköping University hospital, Linköping.
• Geographical residence no further from hospital than permitting visit to Supervised Exercise Training 3 times per week

You may not qualify if:

• Any concommitant heart disease
• Other surgical intervention at time of valve replacement
• Age under 18 years
• Symptomatic lung disease
• Any disability or disease hampering participation in exercise training
• Cannot communicate with spoken Swedish

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Heart and Medicine Center, Linköping University Hospital

Linköping, Östergötland County, Sweden

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Motor Activity

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eva Nylander, PhD

  Linkoeping University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, BSc, Physiotherapist, PhD-student

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 5, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

SE (1)