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MotivationNCT03201081

Motivational Resistance-training Program on Adherence and Body Composition in Elderly

A study testing Motivational resistance-training programme in people with Motivation and Body Weight, run by Universidad Católica San Antonio de Murcia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Motivation, Body Weight
What is being tested?
Motivational resistance-training programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
No sites listed yet
Study dates
15 Jan 2017to 15 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Impact of a Motivational Resistance-training Program on Adherence and Body Composition in Elderly

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.

Read the detailed description

Material and Methods

Participants The study included a total of 47 subjects, (29 females, 18 males) ages 65 to 75 years, recruited from an elderly social club. The participants were divided into two groups: experimental group (n=27; 10 men and 17 female) and control group (n=20; 8 men and 12 female). The sampling was natural and intentional. All subjects originated from Murcia (Spain) and met the following inclusion criteria: had never previously attended classes in fitness academies or were not currently performing regular physical activity, and had no previous experience with resistance-training programmes. Exclusion criteria included any history of neuromuscular, metabolic, hormonal or cardiovascular diseases; not taking any medication that could influence hormonal and neuromuscular metabolism. In addition, the participants were advised to not alter their diet during the study. Participants were informed about the possible risks and discomforts that could arise and were asked to complete a health history questionnaire and sign a consent form. The current study was approved of the Ethics Committee of the Catholic University San Antonio of Murcia (Spain) following the guidelines of the Helsinki Declaration.

Design 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. This same research design has been used in previous studies, which has sought to assess the effect of an intervention programme on body composition, motivational variables and resistance-training.

Data Collection and Procedure Motivational variables Behavioural regulation during exercise. The Spanish version of Behavioural Regulation during Exercise Questionnaire was used. This questionnaire allows to evaluate the type of motivational regulation related to physical exercise, and consists in 23 items distributed in three dimensions, based on the established distinction in the SDT between autonomous motivation, controlled motivation and demotivation. Autonomous motivation was calculated using the mean score of intrinsic regulation (e.g. "Because I think that exercise is fun"), integrated regulation (e.g. "Because I believe that physical exercise is consistent with my values") and identified regulation (e.g. "I value the benefits of exercise"). Each of these regulations was composed of 4 items, except for the identified regulations which was composed of 3 items. Controlled motivation was calculated using the mean score of introjected regulation (e.g. "I feel guilty when I don't exercise") and external regulation (e.g. "I feel under pressure from my friends/family to exercise") with 4 items each. Demotivation (e.g. "I don't see why I should have to exercise") was also calculated using 4 items. Previous research in the physical activity and health context demonstrated the internal reliability of the instrument.

Basic psychological needs during exercise. To assess the perceived need satisfaction of the participants, the Spanish adaptation of the Basic Psychological Needs in Exercise Scale was used (BPNES), which is specific for the context of physical activity and health.67 The questionnaire includes 12 items distributed in three dimensions. Four items measure autonomy (e.g. "I exercise according to what I intend to do"), four items measure competence (e.g. "I feel that physical exercise is an activity that I do very well") and the other four items measure relatedness (e.g. "I have a close relationship with the people with whom I exercise"). Previous research in the physical activity and health context demonstrated the internal reliability of the instrument.

The answers to the questionnaires were assessed on a Likert scale ranging from 1 to 7, where one corresponded with the anchor statement "strongly disagree" and seven with the anchor statement "strongly agree". Before carrying out the intervention, the main researcher contacted with the director of the social club to inform of the purpose of the study. Likewise, all the participants involved were informed about the process that they were going to follow, emphasizing that participation was voluntary. The researcher overviewed how to complete the questionnaire and answered any questions that arose during the process. The different questionnaires were completed in an adequate climate of concentration, with each participant taking approximately 15-20 minutes to complete the questionnaires.

Body composition variables Total body weight was measured, after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA scale, (Tanita Corporation, Arlington Heights, IL) to the nearest 0.1 kg.69 Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm. To minimize the potential source of Bioimpedance systems (BIA) related to total body weight and height, body composition assessment was performed by a level two anthropometrist following International Society for the Advancement of Kinanthropometry recommendations.70 Body Mass Index (BMI) was calculated as the ratio of weight to squared height. BMI was categorized into underweight (<18.50 kg/m2), normal weight (18.50-24.99 kg/m2), overweight (25.00-29.99 kg/m2), and obese (30.00 kg/m2).

Bioelectrical impedance was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles. Fat mass (FM) and muscle mass (MM) were then calculated, using the prediction equation described by Jebb et al. Bioelectrical impedance was chosen due to its ease of use and less invasive nature, making it suitable for assessment of body composition in vulnerable populations such as obese individuals and elderly.

Multi-dimensional intervention programme Prior to the commencement of the study, the subjects were submitted to two weeks of training, two sessions per week, in order to be familiarized with the resistance-training exercises performed in the current study. During this familiarization period, a higher emphasis was placed on learning the proper exercise techniques, and brief pauses between repetitions were allowed in order to reset their starting positions when necessary. During the second week of the familiarization period, a pre-test of the motivational variables was performed, as well as measuring weight, height, BMI, FM and MM. Both pre-test and post-test were carried out in one day between 8:00 and 9:00 a.m. After the pre-test, the experimental group underwent a resistance-training programme for 12 weeks, where different motivational strategies were used. The resistance-training programme incorporated resistance exercises of six major regions and consisted in 3 training sessions per week on non-consecutive days (Monday, Wednesday, and Friday). The six regions were chest, back, triceps, biceps, shoulders and legs. The different regions were grouped into a circuit. The control group, on the other hand, did not participate in the resistance-training programme.

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. A 1-2 minutes resting period was allowed between sets.

All training sessions were monitored by an experienced physical education professional and the subjects were not allowed to perform any additional exercises during the training period. During the training weeks, participants were instructed not to change dietary habits or perform additional non-resistance-training related physical activity.

In addition, with the objective of increasing the adherence to the resistance-training programme, a series of motivational strategies were performed.

The strategies to motivation assessment used were based on the principles of the Self-Determination Theory (SDT). SDT includes a meta-theory for framing motivational studies, a formal theory that defines intrinsic and varied extrinsic sources of motivation, their role in cognitive and social development, as well as in individual differences. SDT is a theory of motivation and personality that addresses three universal, innate and basic psychological needs: autonomy, competence and relatedness. During the resistance-training programme, the subjects received verbal motivational strategies, based on previous studies which have proven the beneficial effect they exert on BPN satisfaction and autonomous motivation.

Being tested
Motivational resistance-training programme
Keywords
elderly, motivation, adherence, resistance-training, health
Medical subject headings
Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational resistance-training programmeOther

    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.

Study groups in NCT03201081
Study groupRoleWhat they receive
training groupExperimentalThe 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.
Receives: Other: Motivational resistance-training programme
control groupNo interventionThe control group, did not participate in the motivational resistance-training program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline behavioural regulation during exercise at 12 weeks

  2. 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.

    Measured: Change from Baseline Basic psychological needs during exercise at 12 weeks

Secondary outcomes (5)
  1. Change of body weight (kg)

    After removal of shoes and heavy outer clothing,using a Tanita BC-418 MA scale, (Tanita Corporation, Arlington Heights, IL) to the 24 nearest 0.1 kg

    Measured: Change from Baseline body weight (kg) at 12 weeks

  2. Change of standing height (cm)

    Assessed without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.

    Measured: Change from Baseline standing height (cm) at 12 weeks

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

    was calculated as the ratio of weight to squared height

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

  4. Change of bioelectrical impedance Muscle mass (kg)

    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.

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

  5. Change of bioelectrical impedance Fat mass (%)

    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start15 Jan 2017
  3. Primary completion15 Jun 2017
  4. Study completion15 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201081
Sponsor's protocol ID
PMAFI/03/12
Status last verified
Jun 2017
First submitted
19 Jun 2017
Last updated
28 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational resistance-training programme in people with Motivation and Body Weight, run by Universidad Católica San Antonio de Murcia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of behavioural regulation during exercise (time frame: Change from Baseline behavioural regulation during exercise at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017; AzTrials last refreshed its copy on 28 Oct 2026.

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