Improving Mobility in Diabetic Patients Through Resistance Training

NCT00759265 | Completed

• 1 other identifier: 06-3-031
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life. The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.

Conditions

Diabetic Patients With Polyneuropathy

Keywords

Muscle strength; Physical activity; Mobility; Gait analysis

Outcome Measures

Primary Outcomes (1)

• Mobility

  0 month, 3 months, 6 months, 12 months

Study Arms (2)

resistance training

EXPERIMENTAL

During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.

Other: resistance training

control

NO INTERVENTION

No intervention was prescribed

Interventions

resistance training OTHER

During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.

resistance training

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic patients with polyneuropathy:
• valkscore \>5;
• diabetic type 2;
• age \>50 years

You may not qualify if:

• muscular related diseases;
• ischemia;
• amputation (except for toe amputation)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Academic Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• Melai T, Schaper NC, Ijzerman TH, de Lange TL, Willems PJ, Lima Passos V, Lieverse AG, Meijer K, Savelberg HH. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013 Oct 18;6(1):41. doi: 10.1186/1757-1146-6-41.

  PMID: 24138784 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Teunis H IJzerman, MSc

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

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: September 24, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 7, 2015

Record last verified: 2010-07

Locations

NL (1)