Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients

NCT01007838 | Completed Results

• 1 other identifier: R& D Ref no: MACDONALD 07/53
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis. It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.

Conditions

Chronic Kidney Disease

Keywords

Progressive Resistance Training/Exercise; Muscle wasting; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Muscle Cross Sectional Area

  Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.

  Change from baseline in cross sectional area at 12 weeks

Secondary Outcomes (1)

• Muscle Strength

  Change from baseline in muscle strength at 12 weeks

Study Arms (4)

Chronic kidney disease progressive resistance training group

EXPERIMENTAL

Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.

Other: Progressive resistance training programme

Chronic kidney disease sham exercise group

SHAM COMPARATOR

Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Other: Sham exercise

Healthy controls progressive resistance training group

EXPERIMENTAL

Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.

Other: Progressive resistance training

Healthy controls sham exercise group

SHAM COMPARATOR

Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Other: Sham exercise

Interventions

Progressive resistance training programme OTHER

Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.

Also known as: Intradialytic resistance exercise

Chronic kidney disease progressive resistance training group

Sham exercise OTHER

Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Chronic kidney disease sham exercise group

Progressive resistance training OTHER

Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.

Healthy controls progressive resistance training group

Eligibility Criteria

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

You may qualify if:

• Chronic kidney diseases stage five requiring maintenance hemodialysis.

You may not qualify if:

• Patients who have been receiving dialysis for less than 3 months;
• Are under the age of 18years;
• Have medical contradictions to participate in the exercise programs;
• Any uncontrolled medical condition which does not allow participation in exercise;
• Have known neuro-muscular disorders;
• Have any other uncontrolled medical condition, including pregnancy;
• Are not independently ambulant for 50 m;
• Have received anabolic intervention, or had catabolic conditions within the last 3 months;
• Have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance;
• Are vulnerable to heat stress;
• Or are unable to give consent.

Sponsors & Collaborators

• Bangor University: lead
• Betsi Cadwaladr University Health Board: collaborator

Study Sites (1)

Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Bangor, Gwynedd, LL57 2PW, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Muscular Atrophy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; 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; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Limitations and Caveats

Small sample size in healthy control group. Variable gender mix in all groups.

Results Point of Contact

• Title: Danielle Kirkman
• Organization: UWalesBangor

pepa03@bangor.ac.uk

00 44 1248 388254

Study Officials

• Jamie H MacDonald, PhD

  Bangor University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: November 4, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 5, 2012
• Results First Posted: December 23, 2011

Record last verified: 2011-12

Locations

GB (1)