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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 24 August 2020
Main ID:  ISRCTN10967873
Date of registration: 23/03/2018
Prospective Registration: No
Primary sponsor: Regional Research Council Vestlandet
Public title: Effects of resistance training on muscle strength and physical activity in frail older people
Scientific title: Effects of resistance training on muscle properties, physical function and physical activity among frail older people: a randomized controlled trial.
Date of first enrolment: 01/09/2016
Target sample size: 120
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN10967873
Study type:  Interventional
Study design:  Randomised parallel-group controlled trial (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Norway
Contacts
Name: Atle    Saeterbakken
Address:  Faculty of Teacher Education, Culture and Sport Western Norway University of Applied Sciences PB 133 N-6851 Sogndal Norway
Telephone: +47 (0)57766000
Email: atle.saeterbakken@hvl.no
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Aged >70 years
2. Living at home
3. Receiving home care due to functional and/or medical disabilities

Exclusion criteria: 1. Serious mental disorders and/or diagnoses/conditions that prevent testing or training

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Frailty in people aged over 70 years
Musculoskeletal Diseases
Sarcopenia
Intervention(s)

This research project will be conducted in three municipalities in the Sogn og Fjordane county. The three municipalities have approximately 16,000 residents and have representative municipal nurse and care services comparable to other small- and medium sized municipalities. All participants receive nurse and care services but live in their own home.

Before starting the trial, we conducted a pilot study examining the ability to conduct a resistance training program with the elderly. The pilot study recruited elderly from one municipality who undertook the program twice a week for 10 weeks. The study design was stratified by six and volunteers were randomised into a control and intervention group.

A two-armed parallel group cluster randomised controlled trial was conducted. Participants were elderly people living in three municipalities in Sogn and Fjordane County (Sogndal, Leikanger and Luster). Clusters were based on geographical location, based on the residency of the participants. 12 clusters were identified and cluster size ranged from 5 to 16 participants. The study will be reported according to the CONSORT statement extension to cluster randomized trials.

Intervention group: The intervention was applied on participant level. Project co-workers organised and implemented 30–45 minutes of group-based resistance training (RT) twice a week for 10 months. The sessions were held at the nurse and care centres. The training consisted of exercises aiming to strengthen and increase muscle mass of the large muscle groups often used in daily living. To ensure progression, the training load and volume were increased by introducing new exercises and increasing series and resistance. All repetitions were tobe perf
Primary Outcome(s)

Pilot study (10 weeks)
In the pilot study, the primary outcome was feasibility of performing the resistance training program with frail people.

Main trial (3 years): Outcomes were assessed every 6 months
The primary outcome was the ability to live self-reliantly and independently in their own home.
Secondary Outcome(s)

Pilot study: The following measurements were taken at baseline and after the 10 weeks of intervention.
1. Physical function assessed using time up and go, preferred and maximum walk speed, chair-raise and stair-climb)
2. Muscle strength assessed by maximal isometric contraction and rate of force development in leg and arm)
3. Daily physical activity measured by ActiGraph GT1M over a 5-day period.

Main trial: Endpoints were assessed every 6 months
1. Physical function (time up and go, preferred and maximum walk speed, chair-raise and stair-climb)
2. Muscle strength (maximal isometric contraction and rate of force development in leg and arm)
3. Daily physical activity measured by ActiGraph GT1M over a 14-day period
4. Quality of life using EQ-5D-5L questionnaire
5. Fear of falling using Short FES I questionnaire
Secondary ID(s)
N/A
Source(s) of Monetary Support
Regional Research Council Vestlandet
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
REK sør-øst B, 15/03/2016, 2016/ 51
Results
Results available: Yes
Date Posted:
Date Completed: 30/06/2019
URL:
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