PA-LSS: Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03452449
• Collaborator: (none)
• Enrollment: 29
• Locations: 2
• Actual Duration (Months): 24.9
• Patients Per Site: 14.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spine Degeneration; Physical Activity; Quality of Life; Disability Physical; Pain	Procedure: planned lumbar spine surgery

Detailed Description

Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Lumbar spine surgery Patients undergoing planned lumbar spine surgery	Procedure: planned lumbar spine surgery; planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy

Outcome Measures

Primary Outcome Measures

1. Physical activity [up to 12 weeks]

   measured using ActiGraph (accelerometer based activity monitor) as step counts, physical activity intensity during 7-day data capture period

Secondary Outcome Measures

1. Disability [up to 12 weeks]

   measured using Oswestry Disability Index (questionnaire) (best score: 0 - no disability, worst score: 100)

2. Quality of life assessed by questionnaire [up to 12 weeks]

   measured using Short Form (SF)-36 (questionnaire) (worst score: 0; best score: 100 - highest quality of life)

3. Pain assessed by questionnaire [up to 12 weeks]

   measured using 10 cm visual analogue scale (VAS) lower back, legs (best score: 0 - no pain; worst score: 100)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• primary lumbar spine surgery

• single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)

• German speaking

Exclusion Criteria:

• stabilisation or fusion surgery or surgery above L2

• previous lumbar spine surgery

• indication: scoliosis, fracture, trauma, infection, tumor

• limited walking ability due to other conditions

• psychiatric conditions or dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Orthopaedics and Traumatology, University Hospital basel	Basel	Basel Stadt	Switzerland	4031
2	Bethesda Spital AG	Basel		Switzerland	4002

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Study Chair: Corina Nüesch, PhD, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03452449
• Other Study ID Numbers: 2017-00672
• First Posted: Mar 2, 2018
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: activity monitor; questionnaire; Oswestry Disability Index

Study Results

No Results Posted as of Sep 18, 2019