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Promoting Physical Activity in the Over 65s (ProAct65+)

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ClinicalTrials.gov Identifier: NCT00726531
Recruitment Status : Unknown
Verified July 2010 by University College, London.
Recruitment status was:  Recruiting
First Posted : August 1, 2008
Last Update Posted : July 8, 2010
Sponsor:
Collaborator:
University of Nottingham
Information provided by:
University College, London

Brief Summary:

The aim of the project is to evaluate the delivery, impact and cost effectiveness of a community based exercise programme (FaME); compared to a home based exercise programme (OEP) supported by similarly aged mentors; compared with usual care for primary care patients.

Primary Objective:

  1. To determine the effect on continuation of exercise of two evidence based exercise programmes designed for older people, compared with usual care i.e. with no special interventions to promote physical activity.

    Secondary Objective:

  2. To determine the health benefits of the programmes to patients starting at various levels of physical activity, particularly the effects on physical and psychological status, health status and quality adjusted life years (QALYs).
  3. To estimate the costs of the exercise interventions and to assess the cost-effectiveness of community group exercise, and home-supported exercise compared with usual care.
  4. To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.
  5. To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.

Condition or disease Intervention/treatment Phase
Falls Behavioral: Otago Exercise Programme Behavioral: Fame Other: Treatment As Usual Phase 3

Detailed Description:
A cluster controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby), to compare a community-centre based group exercise programme - FaME [delivered by specifically trained postural stability instructors (PSIs) and supplemented by home exercise and prescriptive recommendations for walking], with a home based exercise programme and walking plan - OEP [supported by specifically trained and similarly aged mentors], with two years follow-up to determine the impact, acceptability and adherence to the programme, and longer term continuation of exercise. Control subjects will continue to receive usual care in primary care. A cost-effectiveness analysis will be conducted within the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care
Study Start Date : June 2008
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OEP
Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require
Behavioral: Otago Exercise Programme
Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require

Experimental: Fame
Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.
Behavioral: Fame
Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.

No Intervention: TAU
Treatment as usual
Other: Treatment As Usual
Treatment as usual by the general practitioner
Other Name: Usual clinical care




Primary Outcome Measures :
  1. type, intensity, duration and frequency of physical activity [ Time Frame: two years after intervention ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible patients will be those aged 65+ who can walk around at home (i.e. not chair or bed bound) and would be physically able to take part in a group exercise class, who are not already receiving any long term physiotherapy and who do not fulfill the exclusion criteria.

Exclusion Criteria:

  • Chair or bed bound
  • Receiving long-term physiotherapy
  • Three or more falls in the previous year i.e. frequent fallers (only excluded if their GP does not consent to them taking part in exercise)
  • Resting BP > 180/100 mmHg, tachycardia > 100bpm, uncontrolled hypertension
  • Significant drop in BP during exercise
  • Psychiatric conditions or physical abilities which would prevent participation in an exercise class (for example psychotic illness, acute systemic illness (e.g. pneumonia), uncontrolled visual or vestibular disturbances which the GP considers would exclude patients from undertaking the exercise programme, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure, or conditions requiring a specialist exercise programme e.g. uncontrolled epilepsy significant neurological disease or impairment, unable to maintain seated upright position or unable to move about independently indoors)
  • Not living independently (e.g. residential care)
  • Significant cognitive impairment (unable to follow simple instructions)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726531


Contacts
Contact: Steve Iliffe, MB BS, BSc 00442078302393 s.iliffe@ucl.ac.uk

Locations
United Kingdom
University College London Recruiting
London, United Kingdom
Principal Investigator: Steve Iliffe         
University of Nottingham Recruiting
Nottingham, United Kingdom
Principal Investigator: Denise Kendrick         
Sponsors and Collaborators
University College, London
University of Nottingham
Investigators
Study Director: Denise Kendrick, PhD University of Nottingham

Responsible Party: Professor Steve Iliffe, University College London
ClinicalTrials.gov Identifier: NCT00726531     History of Changes
Other Study ID Numbers: ProAct65+
UK HTA grant 06/36/04
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: July 2010

Keywords provided by University College, London:
Falls prevention
Exercise promotion
Older people