1. To investigate the impact of various resistance-type exercise variables (i.e. load, repetitions, volume) on skeletal muscle mass, strength and physical performance outcomes in (mal)nourished frail community-dwelling older adults.2. To investigate…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Ondervoeding & Geriatrische syndromen (zoals sarcopenie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the change in muscle strength between baseline and
twelve- weeks, and is accessed with a one repetition maximum tests (1-RM).
Secondary outcome
- social demographic characteristics
- medical history / medication use
- cognitive ability
- body composition
- muscle architecture
- inflammation markers, glucose and insulin levels
- physical performance
- handgrip strength
- activities of daily living
- quality of life
- malnutrition
- daily dietary intake
- daily physical activity
- cognitive performance
- psychosocial outcomes
- sleep quality
- cost-effectiveness
- adverse events / medical status
- adherence
- process evaluation
Background summary
The world population is aging rapidly. As society ages, the incidence of
physical limitations and frailty is dramatically increasing, which reduces the
quality of life and increases health care expenditures. An important cause of
physical limitations and frailty is the age-related loss of skeletal muscle
mass, strength and performance also referred to as sarcopenia. Resistance-type
exercise training is the most promising intervention to prevent or treat
sarcopenia in older adults. Evidence of resistance exercise training is based
on well-controlled studies, but the current protocols are difficult to apply in
daily physiotherapy practice for this frail community-dwelling population. In
addition, about 40% of the frail community-dwelling older adults receiving
in-home services are undernourished. More research is warranted on the impact
of resistance exercise training and (in)adequate dietary protein intake on
training adaptations and sarcopenia in frail older adults.
Study objective
1. To investigate the impact of various resistance-type exercise variables
(i.e. load, repetitions, volume) on skeletal muscle mass, strength and
physical performance outcomes in (mal)nourished frail community-dwelling older
adults.
2. To investigate the impact of various resistance-type exercise variables
(i.e. load, repetitions, volume) during (in)adequate protein intake on
skeletal muscle mass, strength and physical performance outcomes in frail
community-dwelling older adults.
3. To assess the influence of personal characteristics on resistance-type
exercise variables and skeletal muscle mass, strength and physical performance
outcomes in frail community-dwelling older adults.
Study design
(Cluster) Randomized controlled trial, with two step randomization and two
parallel intervention groups.
Intervention
Control group receiving intervention:
- Resistance exercise training, twice weekly for 12 weeks in which subjects
will be randomized by intensity (%1RM)
- Regular health care (+ information flyer)
Intervention group receiving additional dietary protein intervention:
- Resistance exercise training, twice weekly for 12 weeks in which subjects
will be randomized by intensity (%1RM
- Dietary protein intervention: combination of 1) blended dietary counselling,
2) protein enriched consumer products
Study burden and risks
The risks associated with participation are minimal. Although muscle injury,
soreness, and strain on energy levels might occur due to exercise, the risks
are limited. Resistance exercise training takes place in small groups and
participants choose their own number of repetitions during exercise.
Assessments will be executed in a private controlled setting and interventions
are guided by a physical therapist and dietetics. All older adults should
benefit from this study (exercise induced performance and body composition
benefits, social aspects, personal health insights). The results of this trial
can lead to evidence-based practice protocols in physical exercise therapy,
dietetics, and geriatrics.
De boelelaan 1117
Amsterdam 1081 HV
NL
De boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Community-dwelling older adult, receiving in-home care services
* Aged 65 or older
* Physical ability and willingness to execute a resistance exercise program
* Ability and willingness to comply with the protocol
* Willingness that general practitioner will be notified on study participation
* Written informed consent
* Consent of the study physician (ability to comply with the protocol in the
opinion of the study physician, to ensure safety for the participants)
Exclusion criteria
* Inability to understand the Dutch language
* Cognitive impairment (MMSE <15)
* Diagnosed unstable coronary heart disease (CHD), decompensated heart
failure, uncontrolled hypertension or uncontrolled arrhythmias (e.g. hart
failure NYHA >3)
* Diagnosed degenerative neurocognitive disorders
* COPD GOLD >3
* Use of total parenteral nutrition (TPN)
* Active medical treatment interfering with this intervention (e.g. cancer
patients following systemic and immune therapy)
* Physical disabled (walking aids or mild visual impairment are not an
exclusion criteria)
* Current enrollment in a fixed rehabilitation program or other intervention
studies
* Palliative treatment or a life expectancy of <=3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | NL |
| CCMO | NL74601.029.20 |