Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

NCT01161329 | Completed Phase 1 Results DMC

• 3 other identifiers: Dnr2009/067Dnr 2009/067468063005
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic conditions such as stroke are associated with physical disability and an economic burden for the family and the society. A medical approach is often not sufficient to address the bio-psychological process of chronic disease. Behavioural medicine approaches are often needed to improve the treatment outcomes. Those approaches have often successfully been used together with physical activity to change health behaviour in inactive individuals and in pain management. In this project the combined approach of behavioural medicine principles and physical training will be tried on patients who have had a stroke one year ago where it has yet only been used scarcely. As the study focus on the individuals' ability to function and be active the primary outcome measure is disability. The aim of the study are in a randomized controlled study evaluate if a high intense functional exercise program as an group intervention under three months can influence functional, psychosocial, anthropometric and biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome variables will be analyzed:

1. 1.level of physical activity, motor function and balance
2. 2.depression and health-related quality of life
3. 3.body mass index (BMI), metabolic risk profile, inflammation status
4. 4.number of falls, fall-related self-efficacy and outcome expectations

Conditions

Stroke

Keywords

stroke; physical activity; balance; muscle-strength

Outcome Measures

Primary Outcomes (2)

• The Berg Balance Scale (BBS)

  Total score on the scale: 0-56 Points. Higher scores indicates better balance.

  baseline, after 3, 6 months and after 1 year

• Short Physical Performance Battery (SPPB)

  Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.

  Baseline, after 3, 6 months and after 1 year

Study Arms (2)

Control group

NO INTERVENTION

Participants in the control group are instructed to live their ordinary life.

Intervention group

EXPERIMENTAL

Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions.

Other: High-Intensity Functional Exercise Programmes (HIFE)

Interventions

High-Intensity Functional Exercise Programmes (HIFE) OTHER

Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.

Also known as: HIFE-training, strenght-training, Intervention group

Intervention group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient with first-ever stroke in the age of 65-65 years getting their stroke at least one year ago and living in the community.

You may not qualify if:

• Other illness or disability that have an impact on the activity level and participation in tests beside problems after stroke.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala County Council, Sweden: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala university hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Limitations and Caveats

The early termination of the study produced limited Power and increased the risk of type 1-errors.

Results Point of Contact

• Title: Karin Hellström
• Organization: UppsalaU

karin.hellstrom@neuro.uu.se

+46184714762

Study Officials

• Karin Hellström, PhD, RPT

  Uppsala University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Prof. RPT, Senoir lecturer

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2016
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)