Exercise and Vascular Function in Haemodialysis Patients

NCT01591876 | Unknown Phase 2

• 1 other identifier: 12/WS/0129
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.

Conditions

Chronic Kidney Disease Stage 5

Keywords

exercise; kidney disease; vascular function; haemodialysis

Outcome Measures

Primary Outcomes (1)

• Brachial artery flow mediated dilatation

  Brachial artery diameter is measured using vascular ultrasound. A cuff similar to that used for blood pressure is then inflated around the forearm for 5 minutes. Following cuff release vascular ultrasound is used to measure arterial dilation in response to reactive hyperaemia. Relative change in diameter provides a measure of endothelial function. Images are recorded over a period of 4-5 minutes post cuff release.

  Baseline and 12 week follow-up

Secondary Outcomes (9)

• Aortic pulse wave velocity

  Baseline and three month follow-up

• Maximal aerobic power

  Baseline and three months

• Timed up-and-go

  Baseline and three month follow-up

• Sit-to-stand 5

  Baseline and 3 month follow-up

• Non exercise questionnaire

  Baseline and 3 month follow-up

Study Arms (2)

Progressive muscle relaxation

SHAM COMPARATOR

As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation.

Other: Progressive Muscle relaxation

Aerobic exercise

ACTIVE COMPARATOR

Intervention -moderate intensity aerobic exercise.

Other: Intradialytic aerobic exercise

Interventions

Intradialytic aerobic exercise OTHER

Participants in the intervention group will undertake moderate intensity aerobic exercise. Exercise modality will be recumbent cycling during the first two hours of haemodialysis sessions. Exercise prescription is set using a graded exercise test and anchored to a perceived level of exertion using the BORG scale. Training stimulus is maintained by the participant by increasing the cycling resistance when perceived exertion drops by one point at the current resistance level. Adherence and training volume is recorded during the intervention period.

Aerobic exercise

Progressive Muscle relaxation OTHER

This is a sequence of stretching and relaxation of the major muscle groups of the body. Participants are initially given detailed information regarding the technique and then provided with a recorded version which they listen to for 30-40 minutes during dialysis sessions. Participants in this group are offered the exercise programme at the end of three months.

Progressive muscle relaxation

Eligibility Criteria

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

You may qualify if:

• Stage 5 CKD patients (GFR \<15 mL/min) receiving maintenance haemodialysis therapy
• Male or female
• Aged \>18 years
• Written informed consent

You may not qualify if:

• Pregnancy
• Unstable cardiovascular conditions
• Recent cerebrovascular event
• Excess inter-dialytic weight gain
• Use of corticosteroids, anabolic therapies,
• Co-morbid catabolic conditions
• Serum potassium regularly \>6mmol/L
• Recent pulmonary thromboembolism
• Psychiatric illness including anxiety, mood and untreated eating disorders
• Infection or course of antibiotics within one month of study period.
• Dementia or severe cognitive impairment.

Sponsors & Collaborators

• Queen Margaret University: lead
• British Kidney Patients Association: collaborator

Study Sites (1)

Monklands Hospital

Airdrie, ML6 0JS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Kidney Diseases

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tom Mercer, Professor

  Queen Margaret University

  STUDY DIRECTOR

Central Study Contacts

Sean Prescott, MSc

CONTACT

+447980338486; sprescott@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Student

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 4, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

GB (1)