NCT01204567

Brief Summary

The aim of this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect. Design: Randomized controlled trial conducted at Oslo University Hospital, department of Medicine in conjunction with Oslo University College. The subjects will be randomized into one intervention group (training group) or one control group. Outcome measure: Health-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

September 10, 2010

Last Update Submit

August 23, 2012

Conditions

Keywords

HLRQelderlyaerobic fitnesscognitive capacity

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life. Short form Health Survey (SF-36, version 2

    3 and 12 months

Secondary Outcomes (1)

  • Senior fitness test, Cognitive capacity, PASE

    3 and 12 months

Study Arms (1)

Training follow-up after discharge

ACTIVE COMPARATOR

Aerobic training Home-program

Other: Aerobic training

Interventions

Group-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being.

Also known as: 1 intervention group, 1 control group no follow-up
Training follow-up after discharge

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • Be able to perform the Timed Up and Go test without use of assistive device

You may not qualify if:

  • Chronic disease with expected lifespan \< 1 year
  • Exercise regularly more than twice a week
  • Cognitive impairment MMS \< 24
  • Assessed by a doctor not to tolerate aerobic exercises
  • Exercise limiting cardiovascular or musculoskeletal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Study Officials

  • Therese Brovold, phd student

    no afflication

    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 10, 2010

First Posted

September 17, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations