NCT03201081

Brief Summary

Lack of physical activity is one of the major causes for obesity and functional disability in the elderly. Including regular exercise in elderly´s lifestyle is not an easy task. The main objective was to analyse the effect of a motivational resistance-training programme on satisfying the individual´s psychological needs, level of self-determination and body composition. A quasi-experimental study was performed with 47 volunteers (29 females, 18 males) of 67-75 years of age, divided into two groups: experimental (n = 27) and control (n = 20). A 12-week intervention programme was performed, with a total of 36 sessions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 19, 2017

Last Update Submit

June 26, 2017

Conditions

Keywords

elderlymotivationadherenceresistance-traininghealth

Outcome Measures

Primary Outcomes (2)

  • Change of behavioural regulation during exercise

    To evaluate the type of motivational regulation related to physical exercise. The Spanish version of Behavioural Regulation during Exercise Questionnaire was used. This questionnaire allows to 13 evaluate the type of motivational regulation related to physical exercise, and consists in 14 23 items distributed in three dimensions, based on the established distinction in the SDT 15 between autonomous motivation, controlled motivation and demotivation.

    Change from Baseline behavioural regulation during exercise at 12 weeks

  • Change of basic psychological needs during exercise.

    To assess the perceived need satisfaction of the participant. satisfaction of the participants, the Spanish adaptation of the Basic Psychological Needs 4 in Exercise Scale was used. The questionnaire includes 12 items distributed in three 6 dimensions.

    Change from Baseline Basic psychological needs during exercise at 12 weeks

Secondary Outcomes (5)

  • Change of body weight (kg)

    Change from Baseline body weight (kg) at 12 weeks

  • Change of standing height (cm)

    Change from Baseline standing height (cm) at 12 weeks

  • Change of Body Mass Index (BMI): (kg/m^2)

    Change from Baseline Body Mass Index (BMI): (kg/m^2) at 12 weeks

  • Change of bioelectrical impedance Muscle mass (kg)

    Change from Baseline bioelectrical impedance Muscle mass (kg) at 12 weeks

  • Change of bioelectrical impedance Fat mass (%)

    Change from Baseline bioelectrical impedance fat mass (kg) at 12 weeks

Study Arms (2)

training group

EXPERIMENTAL

The training group, based on motivational strategies were performed and a moderate intensity training (8 to 12 repetitions). The load was increased: during the 12 weeks from 65% 1-RM to 80% 1-RM, performing individual more than the prescribed number of repetitions (12 repetitions). A 1-2 minutes resting period was allowed between sets. There was no attempt to control the velocity of the repetitions performed. Prior to each training session, the volunteers performed a specific warmup, consisting of 10 repetitions with approximately 50% of the load used in the first and second exercises of the training session. A total of 36 sessions were performed during the training period. This group was compared with no interventions subjects.

Other: Motivational resistance-training programme

control group

NO INTERVENTION

The control group, did not participate in the motivational resistance-training program.

Interventions

The experimental group exercised at a moderate intensity (8 to 12 repetitions). The load was increased during the 12 weeks from 65% 1-RM to 80% 1-RM. This training load was increased when the individual could perform more than the prescribed number of repetitions (12 repetitions), following the OMNI-RES scale and a hard effort perception level.74 A 1-2 minutes resting period was allowed between sets. During the sessions, the participants were verbally encouraged to perform the complete range of motion for each exercise and received motivational strategies.

training group

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsolder people
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Never previously attended classes in fitness academies or were not currently performing regular physical activity, and had no previous experience with resistance-training programmes

You may not qualify if:

  • Any history of neuromuscular, metabolic, hormonal or cardiovascular diseases; not taking any medication that could influence hormonal and neuromuscular metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A quasi-experimental design (2x2) was developed, dividing the participants into two groups; one experimental and one control. In this design, an initial measurement prior to the intervention (pre-test) and a measurement after the intervention (post-test) were conducted. The sampling was natural and intentional.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 28, 2017

Study Start

January 15, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share