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Completed

NCT Number: NCT01161329

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

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

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uppsala university hospital

Uppsala, 751 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: HIFE-training, strenght-training, Intervention group

Primary outcomes

  1. The Berg Balance Scale (BBS)

    Time frame: baseline, after 3, 6 months and after 1 year

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

  2. Short Physical Performance Battery (SPPB)

    Time frame: Baseline, after 3, 6 months and after 1 year

    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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala County Council, Sweden
  • Uppsala University Hospital

Registry information

Official study title

Description of Physical and Psychosocial Problems One Year After Stroke and the Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Jul 13, 2010
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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