Promoting Physical Activity in the Over 65s

NCT00726531 | Unknown Phase 3 DMC

• 2 other identifiers: ProAct65+UK HTA grant 06/36/04
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

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. 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.
2. 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. 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. 4.To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.
5. 5.To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.

Conditions

Falls

Keywords

Falls prevention; Exercise promotion; Older people

Outcome Measures

Primary Outcomes (1)

• type, intensity, duration and frequency of physical activity

  two years after intervention

Study Arms (3)

OEP

EXPERIMENTAL

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

Fame

EXPERIMENTAL

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

TAU

NO INTERVENTION

Treatment as usual

Other: Treatment As Usual

Interventions

Otago Exercise Programme BEHAVIORAL

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

OEP

Fame BEHAVIORAL

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.

Fame

Treatment As Usual OTHER

Treatment as usual by the general practitioner

Also known as: Usual clinical care

TAU

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead
• University of Nottingham: collaborator

Study Sites (2)

University College London

London, United Kingdom

RECRUITING

University of Nottingham

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Denise Kendrick, PhD

  University of Nottingham

  STUDY DIRECTOR

Central Study Contacts

Steve Iliffe, MB BS, BSc

CONTACT

00442078302393; s.iliffe@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2013
• Last Updated: July 8, 2010

Record last verified: 2010-07

Locations

GB (2)